Cytosorbents Corp - Quarter Report: 2008 March (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 March
31, 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 “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 May
14, 2008 there were 25,044,932 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 (March 31, 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 or Plan of
Operation
|
13
|
|
|
|
|
Item
4. Controls and Procedures
|
14
|
|
|
|
PART
II. OTHER INFORMATION
|
|
|
Item 1. Legal Proceedings |
15
|
|
Item
6. Exhibits
|
15
|
PART
I -- FINANCIAL INFORMATION
Item
1. Financial Statements.
(a
development stage company)
|
|||||||
|
|
|
|||||
CONSOLIDATED
BALANCE SHEETS
|
|||||||
|
|
|
|||||
|
March
31,
|
December
31,
|
|||||
|
2008
|
2007
|
|||||
|
(Unaudited)
|
|
|||||
|
|
|
|||||
ASSETS
|
|
|
|||||
|
|
|
|||||
Current
Assets:
|
|
|
|||||
Cash
and cash equivalents
|
$
|
46,768
|
$
|
211,613
|
|||
Prepaid
expenses and other current assets
|
187,913
|
200,682
|
|||||
|
|||||||
Total
current assets
|
234,681
|
412,295
|
|||||
|
|||||||
Property
and equipment - net
|
122,687
|
144,457
|
|||||
|
|||||||
Other
assets
|
249,203
|
245,820
|
|||||
|
|||||||
Total
long-term assets
|
371,890
|
390,277
|
|||||
|
|||||||
Total
Assets
|
$
|
606,571
|
$
|
802,572
|
|||
|
|||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
|||||||
|
|||||||
Current
Liabilities:
|
|||||||
Accounts
payable
|
$
|
910,123
|
$
|
775,342
|
|||
Accrued
expenses and other current liabilities
|
228,090
|
131,526
|
|||||
Total
current liabilities
|
1,138,213
|
906,868
|
|||||
Long
term liabilities:
|
|||||||
Notes
payable - non-current
|
100,000
|
--
|
|||||
Total
long term liabilities
|
100,000
|
--
|
|||||
Total
liabilities
|
1,238,213
|
906,868
|
|||||
Stockholders’
Equity (Deficit):
|
|||||||
10%
Series A Preferred Stock, Par Value $0.001, 100,000,000 shares
authorized
at March 31, 2008 and December 31, 2007, 8,219,995 and 8,019,508
shares
issued and outstanding, respectively
|
8,219
|
8,019
|
|||||
Common
Stock, Par Value $0.001, 100,000,000 Shares authorized at March
31, 2008
and December 31, 2007, 25,044,932 shares issued and outstanding
|
25,045
|
25,045
|
|||||
Additional
paid-in capital
|
71,719,840
|
71,400,849
|
|||||
Deficit
accumulated during the development stage
|
(72,384,746
|
)
|
(71,538,209
|
)
|
|||
Total
stockholders' equity (deficit)
|
(631,642
|
)
|
(104,296
|
)
|
|||
|
|||||||
Total
Liabilities and Stockholders' Equity (Deficit)
|
$
|
606,571
|
$
|
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
|
|
Three
months ended March 31,
|
|
||||||
|
|
March
31, 2008
|
|
2008
|
|
2007
|
|
|||
|
|
(Unaudited)
|
|
(Unaudited)
|
|
(Unaudited)
|
|
|||
|
|
|
|
|
|
|
|
|||
Revenue
|
|
$
|
--
|
|
$
|
--
|
|
$
|
--
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
42,663,407
|
|
|
355,127
|
|
|
344,411
|
|
Legal,
financial and other consulting
|
|
|
6,706,592
|
|
|
57,924
|
|
|
129,526
|
|
General
and administrative
|
|
|
21,633,599
|
|
|
233,524
|
|
|
685,419
|
|
Change
in fair value of management and incentive units
|
|
|
(6,055,483
|
)
|
|
--
|
|
|
--
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
expenses
|
|
|
64,948,115
|
|
|
646,575
|
|
|
1,159,356
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain
on disposal of property and equipment
|
|
|
(21,663
|
)
|
|
--
|
|
|
--
|
|
Gain
on extinguishment of debt
|
|
|
(216,617
|
)
|
|
--
|
|
--
|
||
Interest
expense (income), net
|
|
|
5,576,521
|
|
|
(525
|
)
|
|
(30,849
|
)
|
Penalties
associated with non-registration of
Series
A Preferred Stock
|
|
|
361,495
|
|
|
--
|
|
320,023
|
|
|
Net
loss
|
|
(70,647,851
|
)
|
(646,050
|
)
|
(1,448,530
|
)
|
|||
Series
A Preferred Stock Dividend
|
1,736,895
|
200,487
|
185,087
|
|||||||
Net
Loss available to common shareholders
|
$
|
(72,384,746
|
)
|
$
|
(846,537
|
)
|
$
|
(1,633,617
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted net loss per common share
|
|
|
|
|
$
|
(0.03
|
)
|
$
|
(0.
07
|
)
|
Weighted
average number of shares of
|
|
|
|
|
|
|
|
|
|
|
common
stock outstanding
|
|
|
|
|
|
25,044,932
|
|
|
24,628,274
|
|
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 March 31, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
Deficit
|
|
|
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|||||||
|
|
|
|
|
|
|
|
|
|
Additional
|
|
During
the
|
|
Total
|
|
|||||||
|
|
Common
Stock
|
|
Preferred
Stock
|
|
Paid-In
|
|
Development
|
|
Stockholders'
|
|
|||||||||||
|
|
Shares
|
|
Par
value
|
|
Shares
|
|
Par
Value
|
|
Capital
|
|
Stage
|
|
Equity
(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
|
|
|
--
|
|
|
--
|
|
|
--
|
|
|
--
|
|
|
118,704
|
|
|
--
|
|
|
118,704
|
|
Issuance
of Series A Preferred Stock as dividends
|
--
|
--
|
200,487
|
200
|
200,287
|
(200,487
|
)
|
--
|
||||||||||||||
Net
loss
|
|
|
--
|
|
|
--
|
|
|
--
|
|
|
--
|
|
|
--
|
|
|
(646,050
|
)
|
|
(646,050
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at March 31, 2008 (Unaudited)
|
|
|
25,044,932
|
|
$
|
25,045
|
|
|
8,219,995
|
|
$
|
8,219
|
|
$
|
71,719,840
|
|
$
|
(72,384,746
|
)
|
$
|
(631,642
|
)
|
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
|
|
Three
months
|
|
Three
months
|
|
|||
|
|
(date
of inception) to
|
|
ended
|
|
Ended
|
|
|||
|
|
March
31, 2008
|
|
March
31, 2008
|
|
March
31, 2007
|
|
|||
|
|
(Unaudited)
|
|
(Unaudited)
|
|
(Unaudited)
|
|
|||
Cash
flows from operating activities:
|
|
|
|
|
|
|||||
Net
loss
|
|
$
|
(70,647,851
|
)
|
$
|
(646,050
|
)
|
$
|
(1,448,530
|
)
|
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
|
|
|
2,262,990
|
|
|
25,925
|
|
|
48,025
|
|
Amortization
of debt discount
|
|
|
1,000,000
|
|
|
--
|
|
|
--
|
|
Gain
on disposal of property and equipment
|
|
|
(21,663
|
)
|
|
--
|
|
|
--
|
|
Gain
on extinguishment of debt
|
|
|
(216,617
|
)
|
|
--
|
|
--
|
||
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
|
|
|
478,409
|
|
|
--
|
|
|
--
|
|
Expense
for issuance of options
|
|
|
1,008,636
|
|
|
118,704
|
|
|
457,085
|
|
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
|
|
|
(459,461
|
)
|
|
12,769
|
|
(8,455
|
)
|
|
Other
assets
|
|
|
(56,393
|
)
|
|
(2,500
|
)
|
|
--
|
|
Accounts
payable and accrued expenses
|
|
|
2,957,424
|
|
|
231,345
|
|
(19,445
|
)
|
|
Accrued
interest expense
|
|
|
1,823,103
|
|
|
--
|
|
--
|
|
|
Dividend/penalty
payable
|
--
|
--
|
320,023
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
Net
cash used by operating activities
|
|
|
(51,491,469
|
)
|
|
(259,807
|
)
|
|
(651,297
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|
Proceeds
from sale of property and equipment
|
|
|
32,491
|
|
|
--
|
|
|
--
|
|
Purchases
of property and equipment
|
|
|
(2,221,851
|
)
|
|
(1,330
|
)
|
|
(21,428
|
)
|
Patent
costs
|
|
|
(409,386
|
)
|
|
(3,708
|
)
|
|
(10,758
|
)
|
Loan
receivable
|
|
|
(1,632,168
|
)
|
|
--
|
|
|
--
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
cash used by investing activities
|
|
|
(4,230,914
|
)
|
|
(5,038
|
)
|
|
(32,186
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|
Proceeds
from issuance of common stock
|
|
|
400,490
|
|
|
--
|
|
|
--
|
|
Proceeds
from issuance of preferred stock
|
|
|
4,679,437
|
|
|
--
|
|
|
--
|
|
Equity
contributions - net of fees incurred
|
|
|
41,711,198
|
|
|
--
|
|
|
--
|
|
Proceeds
from borrowings
|
|
|
8,478,631
|
|
|
100,000
|
|
|
--
|
|
Proceeds
from subscription receivables
|
|
|
499,395
|
|
|
--
|
|
|
--
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
cash provided by financing activities
|
|
|
55,769,151
|
|
|
100,000
|
|
--
|
|
See
accompanying notes to consolidated financial statements.
6
Net
change in cash and cash equivalents
|
|
|
46,768
|
|
|
(164,845
|
)
|
|
(683,483
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents - beginning of period
|
|
|
--
|
|
|
211,613
|
|
|
2,873,138
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents - end of period
|
|
$
|
46,768
|
|
$
|
46,768
|
|
$
|
2,189,655
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
$
|
10,201,714
|
|
$
|
--
|
|
$
|
--
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
$
|
620,563
|
|
$
|
--
|
|
$
|
--
|
|
Series
A Preferred Stock Dividends
|
$
|
1,736,895
|
$
|
200,487
|
$
|
185,087
|
||||
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)
March
31, 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”), formerly known as Gilder Enterprises,
Inc., 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 March
31,
2008 and the results of its operations and cash flows for the three month
periods ended March 31, 2008 and 2007, and for the period January 22, 1997
(date
of inception) to March 31, 2008. Results for the 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 March 31, 2008 of $72,384,746.
The
Company is not currently generating revenue and is dependent on the proceeds
of
present and future financings to fund its research, development and
commercialization program. The Company is continuing its fund-raising
efforts. Although the Company has historically been successful in raising
additional capital through equity and debt financings, there can be no assurance
that the Company will be successful in raising additional capital in the
future
or that it will be on favorable terms. Furthermore, if the Company is
successful in raising the additional financing, there can be no assurance
that
the amount will be sufficient to complete the Company's plans. These
consolidated financial statements do not include any adjustments related
to the
outcome of this uncertainty.
The
Company is a development stage company and has not yet generated any revenues.
Since inception, the Company's expenses relate primarily to research and
development, organizational activities, clinical manufacturing, regulatory
compliance and operational strategic planning. Although the Company has
made advances on these matters, there can be no assurance that the Company
will
continue to be successful regarding these issues, nor can there be any assurance
that the Company will successfully implement its long-term strategic
plans.
The
Company has developed an intellectual property portfolio, including 25 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 March 31, 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. 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.
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.
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
a 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.
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
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.
3.
CONVERTIBLE
NOTES
The
Company has outstanding Promissory Notes in the aggregate principal amount
of
$100,000, with due dates ranging from August 2009 to September 2009, which
bear
interest at the rate of 10% per annum. Should
the Company complete any financing which includes any equity component or
provides for a right to convert into equity, and if the entire principal
of the
Note remains outstanding, holders of the Promissory
Notes
shall have the option to convert, on an all-or-none basis, the entire principal
and outstanding interest of their Notes into the securities issued in such
financing under the same terms, conditions and pricing of said financing
(including warrant coverage, if any). 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) the
price
equal to the purchase price per share of common stock issued (or issuable)
in
the Company’s next round of equity financing.
Such
warrants will have an exercise price
equal to the purchase price per share of common stock issued (or issuable)
in
the Company’s next round of equity financing
and
provide for weighted average anti-dilution price protection.
4.
STOCKHOLDERS'
EQUITY (DEFICIT)
During
the three months ended March 31, 2008 the Company recorded non-cash stock
dividends totaling $200,487 in connection with the issuance of 200,487 shares
of
Series A Preferred Stock as a stock dividend to its preferred shareholders
as of
March 31, 2008. The
Company has estimated the value of the shares issued as stock dividends to
be $1
per share. This valuation is based upon the last completed transaction involving
the underlying preferred shares which occurred in 2006.
During
the three months ended March 31, 2008, the Company issued stock options to
employees, consultants and directors resulting in aggregate compensation
expense
of $118,704, $55,428 and $63,276 of which is presented in research and
development expenses and general and administrative expenses,
respectively.
The
summary of the stock option activity for the three months ended March 31,
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
|
3,014,000
|
$
|
0.25
|
10.0
|
||||||
Cancelled
|
--
|
$
|
--
|
--
|
||||||
Exercised
|
--
|
--
|
--
|
|||||||
Outstanding
March 31, 2008
|
5,112,502
|
$
|
4.01
|
8.1
|
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 ($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
March
31, 2008, the aggregate intrinsic value of options outstanding and currently
exercisable amounted to approximately $0.
The
summary of the status of the Company’s non-vested options for the three months
ended March 31, 2008 is as follows:
|
|
Weighted
|
|||||
|
|
Average
|
|||||
|
|
Grant
Date
|
|||||
|
Shares
|
Fair
Value
|
|||||
|
|
|
|||||
Non-vested,
January 1, 2008
|
173,330
|
$
|
.80
|
||||
Granted
|
3,014,000
|
$
|
.11
|
||||
Cancelled
|
--
|
--
|
|||||
Vested
|
1,134,999
|
$
|
.15
|
||||
Exercised
|
--
|
--
|
|||||
Non-vested,
March 31, 2008
|
2,052,331
|
$
|
.15
|
As
of
March 31, 2008, approximately $352,987 of total unrecognized compensation
cost
related to stock options is expected to be recognized over a weighted average
period of 1.27 years.
As
of
March 31, 2008, 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
|
2,100,000
|
|
$
|
2.00
|
|
|
June
30, 2011
|
339,954
|
|
$
|
2.00
|
|
|
September
30, 2011
|
52,
080
|
$
|
2.00
|
July
31, 2011
|
|||
400,000
|
$
|
2.00
|
October
31, 2011
|
|||
240,125
|
$
|
2.00
|
October
24, 2016
|
As
of
March 31, 2008, the Company has the following warrants to purchase 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 $2.00 per share.
11
5.
COMMITMENTS
AND CONTINGENCIES
Pending
Litigation
In
February 2008, Alkermes,
Inc. commenced an action against the Company in the United States District
Court
for the District of Massachusetts, alleging that the Company’s use of the name
MedaSorb infringes on Alkermes’ registered trademark “MEDISORB.” In the action,
Alkermes seeks an injunction against the Company’s further use of the name
MedaSorb. The Company is currently in settlement discussions with Alkermes
and
expects to resolve the matter shortly, although no assurance can be made
in that
regard.
Employment
Agreements
The
Company has employment agreements with certain key executives through December
2008.The agreements provide for annual base salaries of varying
amounts.
One
of
these agreements includes an anti-dilution provision whereby the employee
is
granted options for the right to obtain 5% of the outstanding stock of the
Company on a fully diluted basis.
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 March 31,
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 March 31, 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.
6.
NET LOSS PER SHARE
Basic
loss per share and diluted loss per share for the three months ended March
31,
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 9,076,921 and 5,928,072
incremental shares at March 31, 2008 and 2007, respectively, as well as shares
issuable upon conversion of Series A Preferred Stock and Preferred Stock
Warrants representing 7,205,996 and 6,659,263 incremental shares at March
31,
2008 and 2007, respectively, have been excluded from the computation of diluted
loss per share as they are anti-dilutive.
7.
SUBSEQUENT EVENTS
In
April
and May of 2008, the Company issued 18-month Promissory Notes in the aggregate
principal amount of $50,000, which bear interest at the rate of 10% per annum.
Should
the Company complete any financing which includes any equity component or
provides for a right to convert into equity, these Notes will
automatically be converted into
the
securities issued in such financing under the same terms, conditions and
pricing
of said financing.
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) 100%
of
the principal amount of the Promissory Note being converted, by (y) the
price
equal to the purchase price per share of common stock issued (or issuable)
in
the Company’s next round of equity financing.
Such
warrants will have an exercise price
equal to the purchase price per share of common stock issued (or issuable)
in
the Company’s next round of equity financing
and
provide for weighted average anti-dilution price protection.
12
Item
2. Management’s Discussion and Analysis or Plan of
Operation.
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.
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 a German Central Ethics Committee. 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 recently made arrangements with several hospitals
in
Berlin to conduct the clinical studies, and those hospitals are now open
for
patient enrollment.
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.
13
Our
research and development costs were, $355,127 and $344,411, for the three
months
ended March 31, 2008 and 2007 respectively. We have experienced substantial
operating losses since inception. As of March 31, 2008, we had an accumulated
deficit of $72,384,746 which included losses from operations of $646,050
for the
three month period ended March 31, 2008. In comparison, we had losses from
operations of $1,448,530 for the three month period ended March 31, 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 $588,651 and $1,029,830 for
the
three month periods ended March 31, 2008 and 2007, respectively.
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 March 31, 2008 we had cash on hand of $46,768, and current liabilities
of
$1,138,213.
Due to
the lack of available funds, we have not paid certain of our senior executives
since February 2008. We currently require additional financing to proceed
with
clinical studies and the attempted commercialization of our proposed products.
Although we continue to discuss funding alternatives with potential
institutional investors, our recent efforts to obtain additional financing
have
been unsuccessful, and 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, 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.
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 March 31, 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 three months ended March 31, 2008 that has
materially affected, or is reasonably likely to materially affect, our internal
control over financial reporting.
14
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 seeks an
injunction against our further use of the name MedaSorb. We are currently
in
settlement discussions with Alkermes and expect to resolve the matter shortly,
although no assurance can be made in that regard.
PART II. OTHER INFORMATION
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
|
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: May 15, 2008 | By: | /s/ David Lamadrid |
Name: David Lamadrid |
||
Title: Chief Financial Officer | ||
(On
behalf of the registrant and as
principal
accounting officer)
|
||
16
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
|
17