ASENSUS SURGICAL, INC. - Quarter Report: 2008 June (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC. 20549
FORM
10-Q
(Mark
One)
x
|
Quarterly
Report Pursuant to Section 13 or 15 (d) of the Securities Exchange
Act of
1934 for the Quarterly Period ended June
30, 2008
|
or
¨
|
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 0-19437
|
|||
SAFESTITCH
MEDICAL, INC.
|
|||
|
|||
(Exact
name of registrant as specified in its
charter)
|
Delaware
|
11-2962080
|
||
|
|||
(State
or other jurisdiction of
incorporation
or organization)
|
|
|
(I.R.S.
employer identification no.)
|
4400
Biscayne Blvd., Suite 670, Miami, Florida
|
33137
|
|||
(Address
of principal executive offices)
|
(Zip
code)
|
Registrant’s
telephone number, including area code: (305)
575-6000
Indicate
by check mark whether the registrant (1) has filed all reports required to
be
filed by Section 13 or 15(d) of the Securities 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.
Yes
x 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
the definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ྑ Accelerated
filer ྑ Non-accelerated
filer ྑ Smaller
reporting company x
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
Yes
ྑ No
x
17,954,521
shares of the Company’s common stock, par value $0.001 per share, were
outstanding as of August 1, 2008.
1
SAFESTITCH
MEDICAL, INC.
(A
Developmental Stage Company)
TABLE
OF CONTENTS FOR FORM 10-Q
|
|
|
PART
I. FINANCIAL INFORMATION
|
|
|
|
|
|
ITEM
1.
|
FINANCIAL
STATEMENTS
|
|
|
|
|
Condensed
Consolidated Balance Sheets as of June 30, 2008 (unaudited) and
December
31, 2007
|
3
|
|
Unaudited
Condensed Consolidated Statements of Operations for the Three and
Six
Months ended June 30, 2008 and 2007, and for the period from September
15,
2005 (inception) to June 30, 2008
|
4
|
|
Condensed
Consolidated Statements of Stockholders’ Equity for the period from
September 15, 2005 (inception) through June 30, 2008
(unaudited)
|
5
|
|
Unaudited
Condensed Consolidated Statements of Cash Flows for the Six Months
ended
June 30, 2008 and 2007, and for the period from September 15, 2005
(inception) to June 30, 2008
|
6
|
|
Notes
to unaudited condensed consolidated financial statements
|
7
|
|
ITEM
2.
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
|
16
|
ITEM
3.
|
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
20
|
ITEM
4T.
|
CONTROLS
AND PROCEDURES
|
20
|
|
|
|
PART
II. OTHER INFORMATION
|
||
|
|
|
ITEM
1.
|
LEGAL
PROCEEDINGS
|
21
|
ITEM
1A.
|
RISK
FACTORS
|
21
|
ITEM
2.
|
UNREGISTERED
SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
|
21
|
ITEM
3.
|
DEFAULTS
UPON SENIOR SECURITIES
|
21
|
ITEM
4.
|
SUBMISSION
OF MATTERS TO A VOTE OF SECURITY HOLDERS
|
21
|
ITEM
5.
|
OTHER
INFORMATION
|
21
|
ITEM
6.
|
EXHIBITS
|
21
|
SIGNATURES
|
22
|
2
(A
Developmental Stage Company)
(in
000s,
except share and per share data)
June
30,
|
December
31,
|
||||||
2008
|
2007
|
||||||
ASSETS
|
(Unaudited)
|
||||||
CURRENT
ASSETS
|
|||||||
Cash and cash equivalents
|
$
|
2,401
|
$
|
631
|
|||
Accounts Receivable - related-party
|
43
|
-
|
|||||
Prepaid expenses
|
82
|
99
|
|||||
Total
Current Assets
|
2,526
|
730
|
|||||
FIXED
ASSETS
|
|||||||
Property and equipment, net
|
196
|
196
|
|||||
OTHER
ASSETS
|
|||||||
Security deposits
|
57
|
56
|
|||||
Deferred financing costs, net
|
1,276
|
1,702
|
|||||
Total Other Assets
|
1,333
|
1,758
|
|||||
LONG-TERM
INVESTMENT, net of valuation adjustment of $1,754
|
-
|
-
|
|||||
TOTAL
ASSETS (Note
6)
|
$
|
4,055
|
$
|
2,684
|
|||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|||||||
CURRENT
LIABILITIES
|
|||||||
Accounts payable and accrued liabilities
|
$
|
324
|
$
|
253
|
|||
Total Current Liabilities
|
324
|
253
|
|||||
Stockholder
loans
|
10
|
10
|
|||||
Commitments
and contingencies (Note 9)
|
|||||||
STOCKHOLDERS’
EQUITY
|
|||||||
Preferred
Stock, $.01 par value per share, 25,000,000 shares authorized,
|
|||||||
no shares issued and outstanding
|
-
|
-
|
|||||
Common
Stock, $.001 par value per share, 225,000,000 shares
authorized,
|
|||||||
17,954,521
and 16,093,016 shares
issued and outstanding, respectively
|
18
|
16
|
|||||
Additional
Paid-in Capital
|
10,741
|
6,582
|
|||||
Deficit
accumulated during the development stage
|
(7,038
|
)
|
(4,177
|
)
|
|||
Total
Stockholders’ Equity
|
3,721
|
2,421
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
4,055
|
$
|
2,684
|
The
accompanying notes are an integral part of these unaudited condensed
consolidated financial statements.
3
SAFESTITCH
MEDICAL, INC.
(A
Developmental Stage Company)
(in
000s,
except share and per share amounts)
Three
Months Ended
June
30,
|
Six
Months Ended
June
30,
|
September
15, 2005 (Inception) to June 30,
|
||||||||||||||
2008
|
2007
|
2008
|
2007
|
2008
|
||||||||||||
REVENUES
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
||||||
COSTS
AND EXPENSES
|
||||||||||||||||
Research
and development
|
804
|
552
|
1,618
|
918
|
4,524
|
|||||||||||
General
and administrative
|
390
|
126
|
806
|
164
|
1,826
|
|||||||||||
Total
Costs and Expenses
|
1,194
|
678
|
2,424
|
1,082
|
6,350
|
|||||||||||
LOSS
FROM OPERATIONS
|
(1,194
|
)
|
(678
|
)
|
(2,424
|
)
|
(1,082
|
)
|
(6,350
|
)
|
||||||
INTEREST
INCOME
|
7
|
1
|
12
|
6
|
65
|
|||||||||||
AMORTIZATION
OF DEBT ISSUANCE EXPENSE
|
(212
|
)
|
-
|
(425
|
)
|
-
|
(708
|
)
|
||||||||
INTEREST
EXPENSE
|
(18
|
)
|
-
|
(24
|
)
|
-
|
(45
|
)
|
||||||||
LOSS
BEFORE INCOME TAX
|
(1,417
|
)
|
(677
|
)
|
(2,861
|
)
|
(1,076
|
)
|
(7,038
|
)
|
||||||
PROVISION
FOR INCOME TAX
|
-
|
-
|
-
|
-
|
-
|
|||||||||||
NET
LOSS
|
$
|
(1,417
|
)
|
$
|
(677
|
)
|
$
|
(2,861
|
)
|
$
|
(1,076
|
)
|
$
|
(7,038
|
)
|
|
WEIGHTED
AVERAGE SHARES OUTSTANDING, BASIC AND DILUTED
|
16,843,415
|
11,256,369
|
16,468,215
|
11,256,369
|
||||||||||||
NET
LOSS PER BASIC AND DILUTED SHARE
|
$
|
(0.08
|
)
|
$
|
(0.06
|
)
|
$
|
(0.17
|
)
|
$
|
(0.10
|
)
|
The
accompanying notes are an integral part of these unaudited condensed
consolidated financial statements.
4
SAFESTITCH
MEDICAL, INC.
(A
Developmental Stage Company)
CONDENSED
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
FOR
THE PERIOD SEPTEMBER 15, 2005 (INCEPTION) THROUGH JUNE 30,
2008
(in
000s)
Preferred
Stock
|
Common
Stock
|
Additional
Paid-in
|
Deficit
Accumulated
During
the
Development
|
|||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Stage
|
Total
|
||||||||||||||||
Inception
- September 15, 2005
|
-
|
$
|
-
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
||||||||||
Capital
contributed
|
-
|
-
|
-
|
-
|
1
|
-
|
1
|
|||||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
(76
|
)
|
(76
|
)
|
|||||||||||||
Balance
at December 31, 2005
|
-
|
$
|
-
|
-
|
$
|
-
|
$
|
1
|
$
|
(76
|
)
|
$
|
(75
|
)
|
||||||||
Capital
contributed
|
-
|
-
|
11,256
|
11
|
1,493
|
-
|
1,504
|
|||||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
(1,060
|
)
|
(1,060
|
)
|
|||||||||||||
Balance
at December 31, 2006
|
-
|
$
|
-
|
11,256
|
$
|
11
|
$
|
1,494
|
$
|
(1,136
|
)
|
$
|
369
|
|||||||||
|
||||||||||||||||||||||
Exercise
of options (CTS) -
September
23, 2007 at $0.79 per share
|
-
|
-
|
42
|
-
|
35
|
-
|
35
|
|||||||||||||||
Stock-based
compensation-September 4, 2007
|
-
|
-
|
-
|
-
|
77
|
-
|
77
|
|||||||||||||||
Issuance
of shares in recapitalization - September 4, 2007 at $0.64 per
share
|
-
|
-
|
4,795
|
5
|
3,078
|
-
|
3,083
|
|||||||||||||||
SafeStitch
expenses associated with recapitalization
|
-
|
-
|
-
|
-
|
(156
|
)
|
-
|
(156
|
)
|
|||||||||||||
Stock-based
compensation
|
-
|
-
|
-
|
-
|
65
|
-
|
65
|
|||||||||||||||
Warrants
issued in connection with credit facility-September 4, 2007 at $2.46
per
share
|
-
|
-
|
-
|
-
|
1,985
|
-
|
1,985
|
|||||||||||||||
Rule
16 payment received
|
-
|
-
|
-
|
-
|
4
|
-
|
4
|
|||||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
(3,041
|
)
|
(3,041
|
)
|
|||||||||||||
Balance
at December 31, 2007
|
-
|
$
|
-
|
16,093
|
$
|
16
|
$
|
6,582
|
$
|
(4,177
|
)
|
$
|
2,421
|
|||||||||
Issuance
of shares in private offering - May 2008 at $2.15 per share, net
of
offering costs
|
-
|
-
|
1,862
|
2
|
3,988
|
-
|
3,990
|
|||||||||||||||
Stock-based
compensation
|
-
|
-
|
-
|
-
|
171
|
-
|
171
|
|||||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
(2,861
|
)
|
(2,861
|
)
|
|||||||||||||
Balance
at June 30, 2008 - Unaudited
|
-
|
$
|
-
|
17,955
|
$
|
18
|
$
|
10,741
|
$
|
(7,038
|
)
|
$
|
3,721
|
The
accompanying notes are an integral part of these unaudited condensed
consolidated financial statements.
5
SAFESTITCH
MEDICAL, INC.
(A
Developmental Stage Company)
(in
000s)
Six
Months Ended June 30,
|
September
15, 2005 (Inception) to June
30,
|
|||||||||
2008
|
2007
|
2008
|
||||||||
OPERATING
ACTIVITIES
|
||||||||||
Net
loss
|
(2,861
|
)
|
(1,076
|
)
|
(7,038
|
)
|
||||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||
Amortization
of deferred finance costs
|
425
|
-
|
708
|
|||||||
Stock-based
compensation expense
|
171
|
-
|
314
|
|||||||
Depreciation
and amortization
|
25
|
-
|
29
|
|||||||
(Increase)
in receivables and other current assets
|
(26
|
)
|
-
|
(105
|
)
|
|||||
(Increase)
in other assets
|
(1
|
)
|
-
|
(58
|
)
|
|||||
Increase
in accounts payable and accrued liabilities
|
72
|
45
|
40
|
|||||||
NET
CASH USED IN OPERATING ACTIVITIES
|
(2,195
|
)
|
(1,031
|
)
|
(6,110
|
)
|
||||
CASH
FLOWS FROM INVESTING ACTIVITIES
|
||||||||||
Purchase
of equipment
|
(25
|
)
|
-
|
(225
|
)
|
|||||
Payment
received under Rule 16b
|
-
|
-
|
4
|
|||||||
NET
CASH USED IN INVESTING ACTIVITIES
|
(25
|
)
|
-
|
(221
|
)
|
|||||
CASH
FLOWS FROM FINANCING ACTIVITIES
|
||||||||||
Net
cash provided in connection with the acquisition of SafeStitch
LLC
|
-
|
-
|
3,192
|
|||||||
Issuance
of 1,861,505 shares of Common Stock, net of offering costs
|
3,990
|
-
|
3,990
|
|||||||
Capital
contributions
|
-
|
-
|
1,431
|
|||||||
Proceeds
from Stockholder loans
|
1,000
|
592
|
1,960
|
|||||||
Repayment
of Stockholder loans
|
(1,000
|
)
|
-
|
(1,876
|
)
|
|||||
Exercise
of options
|
-
|
-
|
35
|
|||||||
NET
CASH PROVIDED BY FINANCING ACTIVITIES
|
3,990
|
592
|
8,732
|
|||||||
NET
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
1,770
|
(439
|
)
|
2,401
|
||||||
CASH
AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
|
631
|
546
|
-
|
|||||||
CASH
AND CASH EQUIVALENTS AT END OF PERIOD
|
2,401
|
107
|
2,401
|
|||||||
Supplemental
disclosures:
|
||||||||||
Cash
paid for interest
|
$
|
24
|
$
|
-
|
$
|
45
|
||||
Non
cash activities:
|
||||||||||
Stockholder
loans contributed to capital
|
$
|
-
|
$
|
-
|
$
|
74
|
The
accompanying notes are an integral part of these unaudited condensed
consolidated financial statements.
6
SAFESTITCH
MEDICAL, INC.
(A
Developmental Stage Company)
NOTES
TO UNAUDITED
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE
1
- BASIS OF PRESENTATION AND LIQUIDITY
The
condensed consolidated balance sheet as of December 31, 2007, which has
been derived from audited financial statements, and the unaudited condensed
consolidated interim financial statements of SafeStitch Medical, Inc.
(“SafeStitch” or the “Company”) have been prepared in accordance with accounting
principles generally accepted in the United States for interim financial
information and the instructions to the quarterly report on Form 10-Q and
Rule 10-01 of Regulation S-X. Accordingly, they do not include all of
the information and footnotes required by generally accepted accounting
principles for complete financial statements. In the opinion of management,
all
adjustments (consisting of normal recurring accruals) considered necessary
for a
fair presentation have been included. Operating results for the three and six
months ended June 30, 2008 are not necessarily indicative of the results that
may be expected for the year ending December 31, 2008. These condensed financial
statements should be read in conjunction with the audited consolidated financial
statements and notes thereto for the year ended December 31, 2007 included
in
the Company’s annual report on Form 10-KSB, as amended, and the Company’s
quarterly report on Form 10-Q for the interim period ended March 31, 2008.
Certain reclassifications have been made to prior periods’ consolidated
financial statements to be consistent with the current period’s
presentation.
SafeStitch
is a developmental stage medical device company focused on the development
of
medical devices that manipulate tissues for endoscopic and minimally invasive
surgery for the treatment of obesity, gastroesophageal reflux disease (“GERD”),
Barrett’s Esophagus, esophageal obstructions, upper gastrointestinal bleeding,
hernia formation and other intraperitoneal abnormalities.
Cellular
Technical Services Company, Inc. (“Cellular”), a non-operating public company,
was incorporated in 1988 as NCS Ventures Corp. under the laws of the State
of
Delaware. On July 25, 2007 Cellular entered into a Share Transfer, Exchange
and
Contribution Agreement (the “Share Exchange”) with SafeStitch LLC, a Virginia
limited liability company. On September 4, 2007, Cellular acquired all of the
members’ equity of SafeStitch LLC in exchange for 11,256,369 shares of its
common stock, which represented a majority of Cellular’s outstanding shares
immediately following the Share Exchange. For accounting purposes, the
acquisition has been treated as a recapitalization of SafeStitch LLC, with
SafeStitch LLC as the acquirer (reverse acquisition). The historical financial
statements prior to September 4, 2007 are those of SafeStitch LLC, which began
operations on September 15, 2005. The accompanying financial statements give
retroactive effect to the recapitalization as if it had occurred on September
15, 2005 (inception). Effective January 8, 2008, Cellular changed its name
to
SafeStitch Medical, Inc. and increased the aggregate number of shares of capital
stock that may be issued from 35,000,000 to 250,000,000, comprising 225,000,000
shares of common stock, par value $0.001 per share (the “Common Stock”), and
25,000,000 shares of preferred stock, par value $0.01 per share. During the
period beginning May 22, 2008 and ended May 28, 2008, the Company issued
1,861,505 shares of Common Stock in a private placement at a price of $2.15
per
share. (See Note 7 - Capital Transactions.)
The
accompanying financial statements have been prepared assuming that the Company
will continue as a going concern. For the period from September 15, 2005
(inception) through June 30, 2008, the Company has accumulated a deficit of
$7.0 million and has not generated revenue or positive cash flows from
operations. The Company has been dependent upon equity financing and loans
from
stockholders to meet its obligations and sustain operations. The Company’s
efforts have been principally devoted to developing its technologies and
commercializing its products. Based upon its current cash position, its $4.0
million line of credit from The Frost Group LLC (the “Frost Group”) and the
Company’s President and CEO, Jeffrey G. Spragens, and by monitoring its
discretionary expenditures, management believes that the Company will be able
to
fund operations without revenues or additional financing for at least the next
twelve months. Although the Company plans to secure additional funds through
the
issuance of equity and/or debt, no assurance can be given that additional
financing will be available to the Company on acceptable terms, or at all.
The
Company’s ability to continue as a going concern is ultimately dependent upon
achieving profitable operations and generating sufficient cash flows from
operations to meet future obligations.
7
SAFESTITCH
MEDICAL, INC.
(A
Developmental Stage Company)
NOTES
TO UNAUDITED
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE
2
- SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Consolidation.
The
condensed consolidated financial statements include the accounts of the Company
and its wholly-owned subsidiaries, Isis Tele-Communications, Inc., which has
no
current operations, and SafeStitch LLC. All inter-company accounts and
transactions have been eliminated in consolidation.
Cash
and cash equivalents.
The
Company considers all highly liquid investments with a maturity of three months
or less when purchased to be cash equivalents. The Company holds cash and cash
equivalent balances in a bank and other financial institutions. Balances in
excess of FDIC limitations may not be insured.
Property
and equipment.
Property
and equipment are carried at cost less accumulated depreciation. Major additions
and improvements are capitalized, while maintenance and repairs that do not
extend the lives of assets are expensed. Gain or loss, if any, on the
disposition of fixed assets is recognized currently in operations. Depreciation
is calculated primarily on a straight-line basis over estimated useful lives
of
the assets.
Research
and development.
Research
and development costs principally represent salaries of the Company’s medical
and biomechanical engineering professionals, material and shop costs associated
manufacturing product prototypes, and payments to third parties for clinical
trials and additional product development and testing. All research and
development costs are charged to expense as incurred.
Patent
costs.
Costs
incurred in connection with acquiring patent rights and the protection of
proprietary technologies are charged to expense as incurred.
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, such as useful lives of property and equipment,
that
affect the reported amounts of assets and liabilities and disclosure of
contingent assets and liabilities at the date of the financial statements and
the reported amounts of expenses during the reporting period. Actual results
could differ from those estimates.
Stock-based
compensation.
The
Company follows Statement of Financial Accounting Standards (“SFAS”) No. 123R,
“Share
Based Payment”
(“SFAS
123R”), which requires all share-based payments, including grants of stock
options, to be recognized in the income statement as an operating expense,
based
on their fair values. Stock-based compensation is included in general and
administrative expenses for all periods presented.
Fair
value of financial instruments.
The
Company follows SFAS No. 157, “Fair
Value Measurements”
(“SFAS
157”), which defines fair value, establishes a framework for measuring fair
value and requires additional disclosures about fair value measurements. The
carrying amounts of cash and cash equivalents, accounts payable, and accrued
expenses approximate fair value based on their short-term maturity. Stockholder
loans are carried at cost.
Long-lived
assets.
In
accordance with SFAS No. 144, “Accounting
for the Impairment or Disposal of Long-Lived Assets,”
the
Company reviews the carrying values of its long-lived assets, including
long-term investments, for possible impairment whenever events or changes in
circumstances indicate that the carrying amounts of the assets may not be
recoverable. Any long-lived assets held for disposal are reported at the lower
of their carrying amounts or fair value less costs to sell.
Income
taxes.
The
Company follows the liability method of accounting for income taxes, as set
forth in SFAS No. 109, “Accounting
for Income Taxes”
(“SFAS
109”). SFAS 109 prescribes an asset and liability approach, which requires the
recognition of deferred tax liabilities and assets for the expected future
tax
consequences of temporary differences between the carrying amounts and the
tax
bases of the assets and liabilities. The Company’s policy is to record a
valuation allowance against deferred tax assets, when the deferred tax asset
is
not recoverable. The Company considers estimated future taxable income or loss
and other available evidence when assessing the need for its deferred tax
valuation allowance.
8
SAFESTITCH
MEDICAL, INC.
(A
Developmental Stage Company)
NOTES
TO UNAUDITED
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Comprehensive
income (loss).
SFAS No.
130, “Reporting
Comprehensive Income (Loss),”
requires
companies to classify items of other comprehensive income (loss) in a financial
statement. Comprehensive income (loss) is defined as the change in equity of
a
business enterprise during a period from transactions and other events and
circumstances from non-owner sources. The Company’s comprehensive net loss is
equal to its net loss for all periods presented.
NOTE
3 - PROPERTY AND EQUIPMENT
Machinery
and equipment consist of the following:
June
30, 2008
|
Estimated
Useful lives
|
||
Machinery
and equipment
|
$
151,000
|
5
years
|
|
Furniture
and fixtures
|
37,000
|
3-5
years
|
|
Software
|
37,000
|
3-5
years
|
|
|
|||
Accumulated
depreciation and amortization
|
(29,000)
|
||
Property
and equipment, net
|
$
196,000
|
Depreciation
of fixed assets utilized in research and development activities is included
in
research and development expense. All other depreciation is included in general
and administrative expense. Depreciation and amortization expense was $12,000
and $25,000, respectively, for the three and six months ended June 30, 2008.
There was no depreciation expense in the corresponding 2007
periods.
NOTE
4
- LONG-TERM INVESTMENT
In
November 1999, Cellular invested in a one-year, $1.0 million 10% convertible
note of KSI, Inc. (“KSI”) and also received warrants to purchase KSI common
stock. All of the outstanding stock of KSI was acquired in August 2000 by
TruePosition, Inc. (“TruePosition”), a majority owned subsidiary of Liberty
Media Corporation (“Liberty Media”). Prior to the acquisition, the convertible
note was exchanged for KSI common stock. Cellular exercised the KSI warrants
and
purchased additional KSI common stock for approximately $754,000. Cellular’s
investment in KSI common stock was exchanged for TruePosition common stock
on
the date of the acquisition. The Company currently holds 191,118 shares of
TruePosition common stock and accounts for the investment in TruePosition using
the cost method. In December 2002, Cellular received certain valuation
information from TruePosition, indicating a range of values for TruePosition.
Based upon its review of available information and communications with Liberty
Media, Cellular concluded there had been an other-than-temporary decline in
the
estimated fair value of its investment and reduced the recorded carrying value
of this investment from its cost basis of $1,754,000 to zero, representing
its
best estimate of the then-current fair value of Cellular’s investment in the net
equity of TruePosition. TruePosition’s operations have been funded by
significant infusions of cash by Liberty Media to date, and the Company’s
investment in TruePosition common stock has been diluted by these advances,
which were converted to preferred stock in late 2002. In August 2007, the
Company and Cellular were informed that Liberty TP Acquisition, Inc., which
held
an aggregate of no less than 90% of TruePosition’s outstanding capital stock,
was being merged into TruePosition. Pursuant to the terms of the merger,
TruePosition’s minority stockholders, including the Company, were entitled to
receive $3.5116 in cash in exchange for each share held. This merger is the
subject of an appraisal action and securities litigation to which the Company
is
a party (see Note 9). It is possible that the Company may receive proceeds
from
the merger, the litigation or other disposition of this investment, but no
such
amount can be estimated at this time.
NOTE
5
- STOCK-BASED COMPENSATION
Cellular’s
1996 Stock Option Plan (the “1996 Plan”) authorized the grant of both incentive
(“ISO”) and non-qualified stock options, up to a maximum of 335,000 shares of
the Company’s Common Stock, to employees of and consultants to the Company. The
exercise price, term and vesting provision of each option grant was fixed by
the
compensation committee of the Board of Directors (the “Compensation Committee”)
with the provision that the exercise price of an ISO may not be less than the
fair market value of the Company’s Common Stock on the date of grant, and the
term of an ISO may not exceed ten years. The Company has not granted any options
under the 1996 Plan since December 31, 2005. The 1996 Plan has expired and
no
new options may be granted under the 1996 Plan.
9
SAFESTITCH
MEDICAL, INC.
(A
Developmental Stage Company)
NOTES
TO UNAUDITED
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
As
of the
date of the Share Exchange, all options issued to former officers and directors
under the 1996 Plan with exercise prices in excess of the then-current share
price of the Company’s Common Stock were cancelled in exchange for the issuance
of 2,000 shares of the Company’s Common Stock per person, for an aggregate
issuance of 6,000 shares of the Company’s Common Stock. The Company recognized
compensation expense of $77,000 on the date of the Share Exchange for the fair
value of the 6,000 shares issued.
The
Company granted 88,667 options outside of plans in September 2007, all of which
had an exercise price of $2.60. The Company determined the estimated aggregate
fair value of these options on the grant date to be $196,000 based on the
Black-Scholes valuation model using the following assumptions: expected
volatility of 82%, dividend yield of 0%, risk-free interest rate of 4.88% and
expected life of 10 years.
On
November 13, 2007, the Board of Directors and a majority of the Company’s
stockholders approved the SafeStitch Medical, Inc. 2007 Incentive Compensation
Plan (the “2007 Plan”). Under the 2007 Plan, which is administered by the
Compensation Committee, the Company may grant stock options, stock appreciation
rights, restricted stock and/or deferred stock to employees, officers,
directors, consultants and vendors up to an aggregate of 2,000,000 shares of
the
Company’s Common Stock, which are fully reserved for future issuance. The
exercise price of stock options or stock appreciation rights may not be less
than the fair market value of Company’s Common Stock at the date of grant and,
within any 12 month period, no person can receive stock options or stock
appreciation rights for more than one million shares of Common Stock.
Additionally, no stock options or stock appreciation rights granted under the
2007 Plan may have a term exceeding ten years.
The
Company granted zero and 148,500 options, respectively, under the 2007 Plan
during the three and six months ended June 30, 2008. The exercise prices of
the
options granted ranged from $3.00 to $3.10 per share. The Company determined
the
estimated aggregate fair value of these options on the grant dates to be
$300,000, and stock option compensation expense related to these grants was
$21,000 and $146,000, respectively, for the three and six months ended June
30,
2008. Total stock-based compensation recorded for the three and six months
ended
June 30, 2008 was $32,000 and $171,000, respectively, and is included in general
and administrative expense. The fair values of options granted are estimated
on
the date of their grant using the Black-Scholes option pricing model based
on
the assumptions included in the table below. The fair value of the Company’s
stock option awards is expensed over the vesting life of the underlying stock
options using the graded vesting method, with each tranche of vesting options
valued separately. Expected volatility is based on the historical volatility
of
the Company’s stock. Due to the short period of time that the Company has been
publicly traded since the Share Exchange, the historical volatilities of similar
publicly traded entities are reviewed to validate the Company’s expected
volatility assumption. The risk-free interest rate for periods within the
contractual life of the stock option award is based on the yield of US Treasury
bonds on the date the stock option award is granted with a maturity equal to
the
expected term of the stock option award granted. The expected life of stock
option awards granted is based upon the “simplified” method for “plain vanilla”
options contained in the United States Securities and Exchange Commission
(“SEC”) Staff Accounting Bulletin No. 107, as amended by SEC Staff Accounting
Bulletin No. 110. Forfeiture rates are based on management’s estimates. During
the three and six months ended June 30, 2007, the Company granted no stock
option awards. The fair value of each option granted during the six months
ended
June 30, 2008 was estimated using the following assumptions.
Expected
volatility
|
88.31%
- 94.46%
|
Expected
dividend yield
|
0.00%
|
Risk-free
interest rate
|
1.96%
- 2.61%
|
Expected
life
|
3.5
- 5.5 years
|
Forfeiture
rate
|
2.50%
|
10
SAFESTITCH
MEDICAL, INC.
(A
Developmental Stage Company)
NOTES
TO UNAUDITED
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
following summarizes the Company’s stock option activity for the six months
ended June 30, 2008:
Shares
|
Weighted
Average Exercise Price
|
Weighted
Average Remaining Contractual Term (Years)
|
Aggregate
Intrinsic Value
|
||||||||||
Outstanding
at December 31, 2007
|
88,667
|
$
|
2.60
|
9.20
|
|||||||||
Granted
|
148,500
|
$
|
3.06
|
6.72
|
|||||||||
Exercised
|
-
|
-
|
-
|
||||||||||
Canceled
or expired
|
-
|
-
|
-
|
||||||||||
Outstanding
at June 30, 2008
|
237,167
|
$
|
2.89
|
7.65
|
$
|
-
|
|||||||
Exercisable
at June 30, 2008
|
87,667
|
$
|
2.97
|
7.34
|
$
|
-
|
|||||||
Vested
and expected to vest at June 30, 2008
|
232,107
|
$
|
2.89
|
7.67
|
$
|
-
|
Of
the
148,500 options granted during the three and six months ended June 30, 2008,
44%
of such options were vested as of June 30, 2008. A summary of the status of
the
Company’s non-vested options and changes during the six months ended June 30,
2008 is presented below.
Stock
Options
|
Weighted
Average Grant Date Fair Value
|
||||||
Non-Vested
at December 31, 2007
|
66,500
|
$
|
2.21
|
||||
Options
Granted
|
148,500
|
2.02
|
|||||
Options
Vested
|
(65,500
|
)
|
1.88
|
||||
Non-Vested
at June 30, 2008
|
149,500
|
$
|
2.16
|
At
June
30, 2008, there was $250,000 of total unrecognized compensation cost related
to
non-vested employee and director share-based compensation arrangements under
the
2007 Plan. That cost is expected to be recognized over a weighted-average period
of 2.28 years.
No
options were exercised during the three and six months ended June 30, 2008.
The
Company granted 6,000 options under the 2007 Plan in July 2008 at an exercise
price of $2.80.
NOTE
6
- CREDIT FACILITY
In
connection with the acquisition of SafeStitch LLC, the Company entered into
a
Note and Security Agreement (the “Credit Facility”) with both the Frost Group,
LLC and Jeffrey G. Spragens, the Company’s Chief Executive Officer and President
and a director. The Frost Group is a Florida limited liability company whose
members include Frost Gamma Investments Trust, a trust controlled by Dr. Phillip
Frost, the largest beneficial holder of the issued and outstanding shares of
the
Company’s Common Stock, Dr. Jane H. Hsiao, the Company’s Chairman of the Board
and Steven D. Rubin, a director. The Credit Facility provides for $4.0 million
in total available borrowings, consisting of $3.9 million from the Frost Group
and $100,000 from Mr. Spragens. The Credit Facility has a term of 28 months,
which expires in December 2009. Outstanding borrowings under the Credit Facility
bear interest at a 10% annual rate.
The
Company granted a security interest in all present and subsequently acquired
collateral in order to secure prompt, full and complete payment of the amounts
due under the Credit Facility. The collateral includes all assets of the
Company, inclusive of intellectual property (patents, patent rights, trademarks,
service marks, etc.).
In
connection with the Credit Facility, the Company granted warrants to purchase
an
aggregate of 805,521 shares of its Common Stock to the Frost Group and Mr.
Spragens. The fair value of the warrants was determined to be $1,985,000 on
the
grant date based on the Black-Scholes valuation model using the following
assumptions: expected volatility of 82%, dividend yield of 0%, risk-free
interest rate of 4.88% and expected life of 10 years. The fair value of the
warrants was recorded as deferred financing costs and will be amortized over
the
life of the Credit Facility. The Company recorded amortization expense of
$212,000 and $425,000 related to these deferred financing costs during the
three
and six months ended June 30, 2008, respectively.
11
SAFESTITCH
MEDICAL, INC.
(A
Developmental Stage Company)
NOTES
TO UNAUDITED
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
Company borrowed $1.0 million under the Credit Facility in the three months
ended March 31, 2008 and repaid the entire outstanding balance during the three
months ended June 30, 2008 with the proceeds of the private placement described
in Note 7. The Company recognized interest expense related to the outstanding
borrowings under the Credit Facility during the three and six months ended
June
30, 2008 of $18,000 and $24,000, respectively. As of June 30, 2008, there was
no
balance outstanding under the Credit Facility.
NOTE
7
- CAPITAL TRANSACTIONS
Share
Exchange.
As
described in Note 1, on September 4, 2007, the Company acquired all of the
members’ equity of SafeStitch LLC in exchange for the issuance of 11,256,369
shares of Cellular’s common stock. For accounting purposes the transaction has
been treated as a recapitalization of SafeStitch LLC whereby all membership
interests of SafeStitch LLC were eliminated, the ordinary shares received in
exchange for those interests were recorded at par value and the difference
between value of the membership interests and the value of the ordinary shares
received was recorded as additional paid-in capital to give effect to the
transaction as of the beginning of the year. Additionally, as of the date of
the
transaction, net assets of Cellular, its ordinary shares and additional paid-in
capital were recorded to reflect the transaction. SafeStitch LLC incurred
$156,000 of transaction costs, which were recorded as a reduction of additional
paid-in capital.
Private
Placement. During
the period beginning May 22, 2008 and ended May 28, 2008, the Company entered
into stock purchase subscription agreements (the “Subscription Agreements”) with
certain private investors (the “Investors”), pursuant to which the Company
agreed to issue an aggregate of 1,861,505 shares (the “Shares”) of its Common
Stock at a purchase price of $2.15 per share. The Company’s Board of Directors
established the $2.15 purchase price based on an approximately 10% discount
to
the average closing price of the Common Stock on the over-the-counter bulletin
board during the five trading days beginning April 23, 2008 and ended April
29,
2008. The Company closed on the issuance of the Shares during the period
beginning May 22, 2008 and ended May 28, 2008. The Company received aggregate
consideration for the Shares of $4,002,000, and has incurred $12,000 of costs
related to the offering, which were recorded as a reduction of paid-in-capital.
Among the Investors acquiring a portion of the Shares were Dr. Hsiao, Jeffrey
G.
Spragens and some of his relatives, Dr. Kenneth Heithoff, a director, Kevin
Wayne, a director, and Frost Gamma Investments Trust. The Company issued the
Shares in reliance upon the exemption from registration under Section 4(2)
of
the Securities Act of 1933, as amended (the “Act”), and Rule 506 of Regulation D
promulgated thereunder. Each Investor represented to the Company that such
person was an “accredited investor” as defined in Rule 501(a) of the Act and
that the Shares were being acquired for investment purposes. The Shares have
not
been registered under the Act and are “restricted securities” as that term is
defined by Rule 144 under the Act. The Company has not undertaken to register
the Shares and no registration rights have been granted to the Investors in
respect of the Shares.
NOTE
8
- BASIC AND DILUTED NET LOSS PER SHARE
Basic
net
loss per common share is computed by dividing net loss by the weighted average
number of common shares outstanding during the period. Diluted net loss per
common share is computed giving effect to all dilutive potential common shares
that were outstanding during the period. Diluted potential common shares consist
of incremental shares issuable upon exercise of stock options and warrants.
In
computing diluted net loss per share for the three and six months ended June
30,
2008 and 2007, no adjustment has been made to the weighted average outstanding
common shares as the assumed exercise of outstanding options and warrants is
anti-dilutive.
12
SAFESTITCH
MEDICAL, INC.
(A
Developmental Stage Company)
NOTES
TO UNAUDITED
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Potential
common shares not included in calculating diluted net loss per share are as
follows:
June
30, 2008
|
June
30, 2007
|
||
Stock
options
|
237,167
|
171,400
|
|
Stock
warrants
|
805,521
|
–
|
|
Total
|
1,042,688
|
171,400
|
NOTE
9
- COMMITMENTS AND CONTINGENCIES
The
Company is obligated under various operating lease agreements for office space.
Generally, the lease agreements require the payment of base rent plus
escalations for increases in building operating costs and real estate taxes.
Rental expense under operating leases amounted to $30,000 and $78,000 for the
three and six months ended June 30, 2008, respectively, and $2,000 and $5,000
for the three and six months ended June 30, 2007, respectively.
The
Company is presently a plaintiff in a securities fraud and appraisal action
in
respect of its ownership of 191,118 shares of common stock of TruePosition,
which was filed November 13, 2007 in the United States District Court for the
District of Connecticut. SafeStitch and other plaintiffs seek damages and other
relief totaling $80 million. In August 2007, the Company was informed that
Liberty TP Acquisition, Inc., which held an aggregate of no less than 90% of
TruePosition’s outstanding capital stock, was being merged into TruePosition.
Pursuant to the terms of the merger, TruePosition’s minority stockholders,
including the Company, became entitled to receive $3.5116 in cash in exchange
for each share held, which the Company and certain other minority stockholders
considered insufficient compensation. The Company and other minority
stockholders brought forth the aforementioned securities fraud and appraisal
action, and on August 10, 2007, the Company entered into a joint shareholder
litigation governance and funding agreement (the “Funding Agreement”) with such
other stockholders. Under the Funding Agreement, the Company agrees to fund
a
portion of the litigation expenses in connection with the appraisal and
securities fraud action. The Company has contributed approximately $45,000
to
date, and management anticipates that the Company will be called upon to fund
additional amounts during the 2008 fiscal year. The Company may elect to
terminate its participation in the Funding Agreement, whereby the Company would
no longer be required to contribute funds; however, the Company would lose
all
rights under the Funding Agreement, including access to any additional
work-product created after the date of termination. Additionally, the Company’s
portion of any proceeds from a favorable disposition of the litigation may
be
reduced if the Company terminates its participation. The outcome of this
litigation is not now known, nor can it be reasonably predicted at this time.
NOTE
10
- RECENT ACCOUNTING PRONOUNCEMENTS
Effective
January 1, 2008, the Company adopted SFAS No. 157, “Fair
Value Measurements”
(“SFAS
157”), which defines fair value, establishes a framework for measuring fair
value and requires additional disclosures about fair value measurements. In
February 2008, the FASB delayed the effective date of SFAS 157 for one year
for
all nonfinancial assets and nonfinancial liabilities, except for those items
that are recognized or disclosed at fair value in the financial statements
on a
recurring basis. Management has determined that the adoption of SFAS 157 did
not
have a material effect on the Company’s consolidated financial statements.
Effective
January 1, 2008, the Company adopted SFAS No. 159, “The
Fair Value Option for Financial Assets and Financial Liabilities- including
an
amendment of FASB Statement 115”
(“SFAS
159”). This statement provides companies with an option to report selected
financial assets and liabilities at fair value. As of June 30, 2008, the Company
has not elected to use the fair value option allowed by SFAS 159. Management
has
determined that the adoption of SFAS 159 did not have a material effect on
the
Company’s consolidated financial statements.
In
December 2007, the FASB issued SFAS No. 160, “Noncontrolling
Interests in Consolidated Financial
Statements-an amendment of ARB No. 51” (“SFAS
160”). SFAS 160 establishes accounting and reporting standards for the
noncontrolling interest in a subsidiary and for the deconsolidation of a
subsidiary. It clarifies that a noncontrolling interest in a subsidiary is
an
ownership interest in the consolidated entity that should be reported as equity
in the consolidated financial statements. SFAS No. 160 will be effective for
the
Company in its fiscal year beginning January 1, 2009. The Company is currently
evaluating the impact of SFAS No. 160 on its consolidated financial
statements.
13
SAFESTITCH
MEDICAL, INC.
(A
Developmental Stage Company)
NOTES
TO UNAUDITED
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
In
December 2007, the FASB issued SFAS No. 141 R “Business
Combinations”
(“SFAS
141R”). SFAS 141R establishes principles and requirements for how the acquirer
of a business recognizes and measures in its financial statements the
identifiable assets acquired, the liabilities assumed and any noncontrolling
interest in the acquiree. SFAS 141R also provides guidance for recognizing
and
measuring the goodwill acquired in a business combination and determines what
information to disclose to enable users of the financial statements to evaluate
the nature and financial effects of a business combination. SFAS 141R will
be
effective for the Company in its fiscal year beginning January 1, 2009. While
the Company has not yet evaluated the impact, if any, that SFAS 141R will have
on its consolidated financial statements, the Company will be required to
expense costs related to any acquisitions consummated after December 31, 2008.
In
December 2007, the FASB ratified the consensus reached on Emerging Issues Task
Force Issue No. 07-1, “Accounting
for Collaborative Arrangements Related to the Development and Commercialization
of Intellectual Property”
(“EITF
07-1”). EITF 07-1 defines collaborative arrangements and establishes
reporting requirements for transactions between participants
in a
collaborative arrangement and between participants in the arrangement and third
parties. EITF 07-1 will be effective for the Company’s fiscal year
beginning January 1, 2009. The Company is currently evaluating the
potential impact of this standard on its consolidated financial
statements.
In
May
2008, the FASB issued SFAS No. 162, “The
Hierarchy of Generally Accepted Accounting Principles”
(“SFAS
162”). SFAS 162 identifies the sources of accounting principles and
the framework for selecting the principles used in the preparation of financial
statements that are presented in conformity with generally accepted accounting
principles (“GAAP”) in the United States. SFAS 162 will become effective 60 days
following the SEC’s approval of the Public Company Accounting Oversight Board
amendments to AU Section 411, “The
Meaning of Present Fairly in Conformity With Generally Accepted Accounting
Principles.”
The
Company does not expect the adoption of SFAS 162 to have a material impact
on
its consolidated financial statements.
NOTE
11
- AGREEMENT WITH CREIGHTON UNIVERSITY
On
May
26, 2006, SafeStitch entered into an exclusive license and development agreement
(the “License Agreement”) with Creighton University, granting the Company a
worldwide exclusive (even as to the university) license, with rights to
sublicense, to all the Company’s product candidates and associated know-how,
including the exclusive right to manufacture, use and sell the product
candidates.
Pursuant
to the License Agreement, the Company is obligated to pay Creighton University,
on a quarterly basis, a royalty of 1.5% of the revenue collected worldwide
from
the sale of any product licensed under the License Agreement, less certain
amounts including, without limitation, chargebacks, credits, taxes, duties
and
discounts or rebates. The License Agreement does not provide for minimum
royalties. Also pursuant to the License Agreement, the Company has agreed to
invest, in the aggregate, at least $2.5 million over 36 months, beginning May
26, 2006, towards development of any licensed product. This $2.5 million
investment obligation excludes the first $150,000 of costs related to the
prosecution of patents, which the Company invested outside of the License
Agreement. The Company is further obligated to pay to Creighton University
an
amount equal to 20 percent of certain of the Company’s research and development
expenditures as reimbursement for the use of Creighton University’s
facilities.
Failure
to comply with the payment obligations above will result in all rights in the
licensed patents and know-how reverting back to Creighton University. As of
December 31, 2007, the Company had satisfied the $2.5 million investment
obligation described above. Pursuant to the License Agreement, SafeStitch is
entitled to exercise its own business judgment and sole and absolute discretion
over the marketing, sale, distribution, promotion and other commercial
exploitation of any licensed products, provided that, if the Company has not
commercially exploited or commenced development of a licensed patent and its
associated know-how by the seventh anniversary of the later of the date of
the
License Agreement or the date such technology is disclosed to and accepted
by
SafeStitch, then the licensed patent and associated know-how shall revert back
to the university, with no rights retained by the Company, and the university
will have the right to seek a third party with whom to commercialize such patent
and associated know-how, unless the Company purchases one or more one-year
extensions.
14
SAFESTITCH
MEDICAL, INC.
(A
Developmental Stage Company)
NOTES
TO UNAUDITED
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE
12
- INCOME TAXES
The
Company accounts for income taxes using the asset and liability method described
in SFAS No. 109, “Accounting
For Income Taxes,”
the
objective of which is to establish deferred tax assets and liabilities for
the
temporary differences between the financial reporting and the tax bases of
the
Company’s assets and liabilities at enacted tax rates expected to be in effect
when such amounts are realized or settled. A valuation allowance related to
deferred tax assets is recorded when it is more likely than not that some
portion or all of the deferred tax assets will not be realized. All of the
Company’s deferred tax assets have been fully reserved by a valuation allowance
due to management's uncertainty regarding the future profitability of the
Company.
The
Company has adopted the provisions of FASB interpretation No. 48 (“FIN 48”)
“Accounting
for Uncertainty in Income Taxes, an interpretation of FASB Statement No.
109.”
The
Company has recognized no adjustment for uncertain tax provisions. SafeStitch
recognizes interest and penalties related to uncertain tax positions in general
and administrative expense, however no such provisions for accrued interest
and
penalties related to uncertain tax positions have been recorded as of June
30,
2008.
The
tax
years 2003 through 2007 remain open to examination by the major tax
jurisdictions in which the Company operates.
NOTE
13
- CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS
The
Company signed a five year lease for office space in Miami, Florida with a
company owned by one of the Company’s major shareholders. The rental payments
under the Miami office lease, which commenced January 1, 2008, are approximately
$8,000 per month for the first year and escalate 4.5% annually over the life
of
the lease. The Company recorded $24,000 and $61,000 of rent expense related
to
the Miami lease for the three and six months ended June 30, 2008.
Dr.
Jane
Hsiao, the Company’s Chairman of the Board, is a director of Great Eastern Bank
of Florida, a bank where the Company maintains a bank account in the normal
course of business. As of June 30, 2008, the Company had $1.0 million on deposit
with Great Eastern Bank of Florida.
Dr.
Hsiao
and Dr. Phillip Frost, the Company’s largest beneficial shareholder, are each
significant shareholders of Non-invasive Monitoring Systems, Inc. (“NIMS”), a
publicly-traded company which leases office space in the same building as the
Company’s Miami headquarters. The Company’s Chief Financial Officer also serves
as the Chief Financial Officer and supervises the accounting staff of NIMS
under
a board-approved cost sharing arrangement whereby the total salaries of the
accounting staffs of the two companies are shared equally. The Company has
recorded reductions to General and Administrative expense for the three and
six
months ended June 30, 2008 of $15,000, to account for the equalization of costs
under this arrangement. Accounts receivable from NIMS were approximately $6,000
as of June 30, 2008.
Dr.
Hsiao, Dr. Frost and directors Steven Rubin and Richard Pfenniger are each
significant shareholders, officers and/or directors of OPKO Health, Inc.
(“OPKO”), another publicly-traded company which leases office space in the same
building as the Company’s Miami headquarters. Certain of the Company’s employees
have from time to time provided consulting services to OPKO on a cost-plus
basis. The Company has recorded reductions to General and Administrative expense
for the three and six months ended June 30, 2008 of $37,000 to account for
the
provision of these services. The amounts charged may not be representative
of
those that would have been charged in an “arms-length” transaction. These
transactions have been ratified by the Audit Committee of the Board of
Directors. Accounts receivable from OPKO were approximately $37,000 as of June
30, 2008.
15
SAFESTITCH
MEDICAL, INC.
Item
2. Management’s
Discussion and Analysis of Financial Condition and Results of
Operations.
This
Quarterly Report on Form 10-Q contains certain forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”),
Section 27A of the Securities Act of 1933, as amended (the “Securities Act”),
and Section 21E of the Securities Exchange Act of 1934, as amended, (the
“Exchange Act”), about our expectations, beliefs or intentions regarding our
product development efforts, business, financial condition, results of
operations, strategies or prospects. You can identify forward-looking statements
by the fact that these statements do not relate strictly to historical or
current matters. Rather, forward-looking statements relate to anticipated or
expected events, activities, trends or results as of the date they are made.
Because forward-looking statements relate to matters that have not yet occurred,
these statements are inherently subject to risks and uncertainties that could
cause our actual results to differ materially from any future results expressed
or implied by the forward-looking statements. Many factors could cause our
actual operations or results to differ materially from the operations and
results anticipated in forward-looking statements. These factors include, but
are not limited to: our ability to obtain additional funding to continue our
operations; our ability to successfully develop, clinically test and
commercialize our product candidates; the timing and outcome of the regulatory
review process for our product candidates; changes in the regulatory
environments of the United States and other countries in which we intend to
operate; our ability to attract and retain key management and scientific
personnel; competition; our ability to successfully prepare file, prosecute,
maintain, defend and enforce patent claims and other intellectual property
rights; our ability to successfully transition from a research and development
company to a marketing, sales and distribution concern, and our ability to
identify and pursue development of additional product candidates, as well as
the
factors contained in “Item 1A - Risk Factors” of our Annual Report on Form
10-KSB, as amended. We do not undertake any obligation to update forward-looking
statements. We intend that all forward-looking statements be subject to the
safe
harbor provisions of the PSLRA. These forward-looking statements are only
predictions and reflect our views as of the date they are made with respect
to
future events and financial performance.
Overview
We
are a
developmental stage medical device company focused on the development of medical
devices that manipulate tissues for endoscopic and minimally invasive surgery
for the treatment of obesity, gastroesophageal reflux disease (“GERD”),
Barrett’s Esophagus, esophageal obstructions, upper gastrointestinal bleeding,
hernia formation and other intraperitoneal abnormalities.
On
September 4, 2007, we completed the acquisition of SafeStitch LLC pursuant
to a
Share Transfer, Exchange and Contribution Agreement, dated as of July 25, 2007
(referred to as the “Share Exchange Agreement”), by and among us, SafeStitch LLC
and the members of SafeStitch LLC. At the closing of the transaction
contemplated by the Share Exchange Agreement (the “Share Exchange”), we issued
an aggregate of 11,256,369 shares of our Common Stock to the former members
of
SafeStitch LLC in exchange for all of their membership interests in SafeStitch
LLC. We also granted warrants to purchase a total of 805,521 shares of our
Common Stock to the Frost Group and Jeffrey G. Spragens in connection with
a
line of credit of up to $4 million that was provided to us simultaneously with
the closing by the Frost Group and Mr. Spragens. The warrants have a ten year
term and an assumed exercise price of $0.25 per share of Common Stock. Dr.
Phillip Frost has a controlling interest in the Frost Group and is the largest
beneficial holder of our Common Stock. Dr. Jane Hsiao and Steven D. Rubin,
two
of our directors, are also members of the Frost Group. Jeffrey G. Spragens
is
our Chief Executive Officer and President and a director. Frost Gamma
Investments Trust, Dr. Phillip Frost, Dr. Jane Hsiao, Steven D. Rubin and
Jeffrey G. Spragens were also beneficial owners of membership interests in
SafeStitch LLC. We incurred customary acquisition related costs in connection
with the Share Exchange.
In
January 2008, we changed our name from Cellular Technical Services Company,
Inc.
to SafeStitch Medical, Inc., and, on February 11, 2008, our trading symbol
on
the OTCBB changed from “CTSC” to “SFES”. In May 2008, we issued an aggregate of
1,861,505 shares of our Common Stock in a private placement for net proceeds
of
approximately $4.0 million. We intend to apply for the listing of our Common
Stock on the American Stock Exchange at such time as we meet the initial listing
requirements set by the exchange.
Product
Development
We
are
developing a portfolio of endoscopic and minimally invasive surgical devices
and
related accessories. Our product portfolio includes a gastroplasty
device for endoscopic bariatric surgery (obesity surgery) and endoscopic repair
of gastroesophageal reflux disorder (GERD), an endoscopic device for excision
and diagnosis of Barrett's esophagus, a Smart Dilator for esophageal strictures,
a hernia repair device, standard and airway bite blocks to be used during
endoscopy and devices for natural orifice transluminal endoscopic surgery
(NOTES). We have utilized our expertise in intraperitoneal surgery to test
certain of our devices in ex
vivo
and
in
vivo
animal
trials and ex
vivo
human
trials, and with certain products, in limited in
vivo
human
trials, and we intend to rapidly, efficiently and safely move into clinical
trials and commercial development for all products . Clinical trials have
begun for our bite block candidates and are anticipated to begin in 2008 for
the
Smart Dilator, and in 2009 for the gastroplasty (obesity/GERD)
device. Development of the Barrett’s Esophagus, hernia and NOTES
devices are progressing over a longer timeframe as we focus our efforts on
the
products that are entering the clinical trial phase. Commercial development
of
our products is subject to approval from the U.S. Food and Drug Administration
and other U.S. and foreign regulatory agencies.
16
SAFESTITCH
MEDICAL, INC.
Critical
Accounting Policies and Estimates
The
discussion and analysis of our financial condition and results of operations
set
forth below under “Results of Operations” and “Liquidity and Capital Resources”
should be read in conjunction with our financial statements and notes thereto
appearing elsewhere in this Form 10-Q. The preparation of these financial
statements requires us to make estimates and judgments that affect the reported
amounts of assets, liabilities, revenues and expenses, and related disclosure
of
contingent assets and liabilities. On an on-going basis, we evaluate our
estimates, including those related to investments, including the carrying value
of our long term investments, property and equipment, contingencies and
litigation. We base our estimates on historical experience and on various other
assumptions that are believed to be reasonable under the circumstances, the
results of which form the basis for making judgments about the carrying values
of assets and liabilities that are not readily apparent from other sources.
A
more detailed discussion on the application of these and other accounting
policies can be found in Note B in the Notes to the Consolidated Financial
Statements set forth in Item 7 of our Annual Report on Form 10-KSB, as amended,
for the year ended December 31, 2007. Actual results may differ from these
estimates.
Accounting
Treatment
Our
acquisition of SafeStitch LLC in accordance with the Share Exchange Agreement
has been accounted for as a recapitalization of SafeStitch LLC, and SafeStitch
LLC is treated as the continuing reporting entity. The transaction is not
accounted for as a business combination because we did not have an operating
business prior to the consummation of the Share Exchange. The transaction was
instead accounted for as a recapitalization of SafeStitch and the issuance
of
stock by SafeStitch (represented by our outstanding shares of Common Stock)
at
the book values of our assets and liabilities, which approximates fair value
with no goodwill or other intangibles recorded.
Treatment
of Warrants and Options
SafeStitch
LLC did not have any outstanding warrants or options and no warrants or options
were assumed by Cellular as a result of the Share Exchange, except warrants
issued in connection with the $4 million line of credit described
above.
Recent
Accounting Pronouncements
Effective
January 1, 2008, we adopted SFAS No. 157, “Fair
Value Measurements”
(“SFAS
157”), which defines fair value, establishes a framework for measuring fair
value and requires additional disclosures about fair value measurements. In
February 2008, the FASB delayed the effective date of SFAS 157 for one year
for
all nonfinancial assets and nonfinancial liabilities, except for those items
that are recognized or disclosed at fair value in the financial statements
on a
recurring basis. We have determined that the adoption of SFAS 157 did not have
a
material effect on our consolidated financial statements.
Effective
January 1, 2008, we adopted SFAS No. 159, “The
Fair Value Option for Financial Assets and Financial Liabilities- including
an
amendment of FASB Statement 115”
(“SFAS
159”). This statement provides companies with an option to report selected
financial assets and liabilities at fair value. As of June 30, 2008, we elected
not to use the fair value option allowed by SFAS 159. We have determined that
the adoption of SFAS 159 did not have a material effect on our consolidated
financial statements.
17
SAFESTITCH
MEDICAL, INC.
In
December 2007, the FASB issued SFAS No. 160, “Noncontrolling
Interests in Consolidated Financial
Statements-an amendment of ARB No. 51” (“SFAS
160”). SFAS 160 establishes accounting and reporting standards for the
noncontrolling interest in a subsidiary and for the deconsolidation of a
subsidiary. It clarifies that a noncontrolling interest in a subsidiary is
an
ownership interest in the consolidated entity that should be reported as equity
in the consolidated financial statements. SFAS No. 160 will be effective for
our
fiscal year beginning January 1, 2009. We are currently evaluating the impact
of
SFAS No. 160 on our consolidated financial statements.
In
December 2007, the FASB issued SFAS No. 141 R “Business
Combinations”
(“SFAS
141R”), which establishes principles and requirements for how the acquirer of a
business recognizes and measures in its financial statements the identifiable
assets acquired, the liabilities assumed and any noncontrolling
interest
in the acquiree. SFAS 141R also provides guidance for recognizing and measuring
the goodwill acquired in a business combination and determines what information
to disclose to enable users of the financial statements to evaluate the nature
and financial effects of a business combination. SFAS 141R will be effective
for
our fiscal year beginning January 1, 2009. While we have not yet evaluated
the
impact, if any, that SFAS 141R will have on our consolidated financial
statements, we will be required to expense costs related to any acquisitions
consummated after December 31, 2008.
In
December 2007, the FASB ratified the consensus reached on Emerging Issues Task
Force Issue No. 07-1, “Accounting
for Collaborative Arrangements Related to the Development and Commercialization
of Intellectual Property”
(“EITF
07-1”). EITF 07-1 defines collaborative arrangements and establishes
reporting requirements for transactions between participants
in a
collaborative arrangement and between participants in the arrangement and third
parties. EITF 07-1 will be effective for our fiscal year beginning January
1, 2009. We are currently evaluating the potential impact of this standard
on our consolidated financial statements.
In
May
2008, the FASB issued SFAS No. 162, “The
Hierarchy of Generally Accepted Accounting Principles”
(“SFAS
162”). SFAS 162 identifies the sources of accounting principles and
the framework for selecting the principles used in the preparation of financial
statements that are presented in conformity with generally accepted accounting
principles (“GAAP”) in the United States. SFAS 162 will become effective 60 days
following the SEC’s approval of the Public Company Accounting Oversight Board
amendments to AU Section 411, “The
Meaning of Present Fairly in Conformity With Generally Accepted Accounting
Principles.”
We do
not expect the adoption of SFAS 162 to have a material impact on our
consolidated financial statements.
Results
of Operations
At
June
30, 2008, we had an accumulated deficit of $7.0 million. This deficit included
losses of $2.9 million for the six months ended June 30, 2008. Since we do
not
generate revenue from any of our product candidates, we expect to continue
to
generate losses in connection with the clinical development of our products
and
development activities relating to our technologies. These research and
development activities are budgeted to expand over time and will require further
resources if we are to be successful. As a result, we believe our operating
losses are likely to be substantial over the next several years.
Three
and Six Months ended June 30, 2008 Compared
to Three and Six Months Ended June 30, 2007
Research
and development expenses were $804,000 and $1,618,000 for the three and six
months ended June 30, 2008, respectively, as compared to $552,000 and $918,000
for the three and six months ended June 30, 2007. These $252,000 and $700,000
respective increases were primarily due to an increase in the amount of research
being performed as we moved further into our research activities, the addition
of research personnel and the establishment of our Miami prototype development
facility in the fourth quarter of 2007. We expect research and development
expenses to continue to increase as we enter into the more advanced stages
of
animal and human clinical trials for our product candidates.
General
and administrative costs were $390,000 and $806,000 for the three and six months
ended June 30, 2008, respectively, as compared to $126,000 and $164,000 for
the
three and six months ended June 30, 2007. These $264,000 and $642,000 respective
increases were primarily related to increases in administrative staffing and
related operating costs, increased legal, accounting and other costs associated
with being a public company and stock-based compensation charges, which
represented $32,000 and $171,000 for the three and six months ended June 30,
2008, respectively. General and administrative expense consists primarily of
salaries and other related costs for persons serving as our executive, finance,
accounting and administration personnel. Other general and administrative
expense includes our stock-based compensation expense, facility-related costs
not otherwise included in research and development expense and professional
fees
for legal and accounting services. We expect that our general and administrative
expense will increase as we add additional personnel and continue to comply
with
the reporting and other obligations applicable to public companies.
18
SAFESTITCH
MEDICAL, INC.
The
increase in interest income from $1,000 and $6,000 for the three and six months
ended June 30, 2007, respectively, to $7,000 and $12,000 for the three and
six
months ended June 30, 2008, respectively, was due to higher average cash
balances as a result of advances under the $4 million credit facility with
the
Frost Group and Jeffery Spragens (the “Credit Facility,” see Note 6 to the
unaudited condensed consolidated financial statements) and the proceeds of
the
private placement. Interest expense also increased from $0 for the three and
six
months ended June 30, 2007 to $18,000 and $24,000 for the three and six months
ended June 30, 2008, respectively, due to the accrual of interest on amounts
outstanding under the Credit Facility during those periods.
Liquidity
and Capital Resources
We
have
funded our operations to date primarily with proceeds from the private placement
of stock and credit facilities available to us, and our management believes
that, absent any reductions of our discretionary expenditures, our cash balance
as of June 30, 2008 of approximately $2.4 million, together with the $4.0
million available under our line of credit will be sufficient to fund our
short-term cash flow requirements for the next twelve months. We have based
this
estimate on assumptions that are subject to change and may prove to be wrong,
and we may be required to use our available capital resources sooner than we
currently expect. Because of the numerous risks and uncertainties associated
with the development and commercialization of our product candidates, we are
unable to estimate the amounts of increased capital outlays and operating
expenditures associated with our current and anticipated clinical trials. Our
operations over the next twelve months will be focused on the continuing
research and development of our products, including our gastroplasty, hernia
and
Barrett’s devices. Even if we are able to bring certain of our other products to
market prior to the end of 2008, we will likely need to raise additional capital
through the issuance of equity and/or debt to continue operations beyond the
next twelve months. There can be no assurance that such additional funding
will
be available on terms acceptable to us or at all.
As
a
result of our significant research and development expenditures and the lack
of
any approved products to generate product sales revenue, we have not been
profitable and have generated operating losses since inception. We expect to
incur losses from operations for the foreseeable future. We do not expect to
generate any revenues until at least the fourth quarter of 2008, and we expect
to incur increasing research and development expenses, including expenses
related to the hiring of personnel and additional clinical trials. We expect
that general and administrative expenses will also increase as we expand our
finance and administrative staff, add infrastructure and incur additional costs
related to being a public company, including the costs of directors’ and
officers’ insurance, investor relations programs and increased professional
fees. Additionally, we expect to be called upon to contribute additional funds
in connection with our involvement as a plaintiff in the TruePosition litigation
for so long as we stay involved in the litigation. Our ability to continue
as a
going concern is ultimately dependent upon achieving profitable operations
and
generating sufficient cash flows from operations to meet future obligations.
Our
future capital requirements will depend on many factors, including the progress
and results of our clinical trials, the duration and cost of discovery and
preclinical development, laboratory testing and clinical trials for our product
candidates, the timing and outcome of regulatory review of our product
candidates, the costs involved in preparing, filing, prosecuting, maintaining,
defending and enforcing patent claims and other intellectual property rights,
the number and development requirements of other product candidates that we
pursue and the costs of commercialization activities, including product
marketing, sales and distribution. We expect to finance some of our future
cash
needs through public or private equity offerings, debt financings or corporate
collaboration and licensing arrangements. We currently do not have any binding
commitments for such additional funding. We may need to raise additional funds
more quickly if one or more of our assumptions prove to be incorrect or if
we
choose to expand our product development efforts more rapidly than we presently
anticipate. We may also decide to raise additional funds even before we need
them if the conditions for raising capital are favorable. The sale of additional
equity or debt securities will likely result in dilution to our stockholders.
The incurrence of additional indebtedness would also likely result in increased
fixed obligations and covenants that could restrict our operations. Additional
equity or debt financing, grants or corporate collaboration and licensing
arrangements may not be available to us on acceptable terms, or at all. If
adequate funds are not available, we may be required to delay, reduce the scope
of or eliminate our research and development programs, reduce our planned
commercialization efforts or obtain funds through arrangements with
collaborators or others that may require us to relinquish rights to certain
product candidates that we might otherwise seek to develop or commercialize
independently.
19
SAFESTITCH
MEDICAL, INC.
Item
3. Quantitative and Qualitative Disclosures about Market
Risk.
Not
required for smaller reporting companies as defined in
Rule
12b-2 of the Exchange Act.
Item
4T. Controls and Procedures.
We
maintain a system of disclosure controls and procedures (as defined in Exchange
Act Rules 13a-15(e) and 15d-15(e)) that is designed to provide reasonable
assurance that information we are required to disclose in the reports we file
or
submit under the Exchange Act, is accumulated and communicated to management
in
a timely manner. Our Chief Executive Officer and Chief Financial Officer have
evaluated this system of disclosure controls and procedures as of the end of
the
period covered by this quarterly report, and believe that the system
is operating effectively to ensure appropriate disclosure. This conclusion
was based on the following:
Our
Chief
Executive Officer and Chief Financial Officer conducted evaluations of our
systems of internal control over financial reporting and disclosure control
(as
defined in Exchange Act Rules 13a-15(f) and 15d-15(f))for the year ended
December 31, 2007 and concluded at that time that our system of internal
controls was not operating effectively, primarily because we did not maintain
a
sufficient complement of personnel with the appropriate level of knowledge,
experience and training in the application of accounting principles generally
accepted in the U.S. (referred to as GAAP) and in internal control over
financial reporting commensurate with our financial reporting obligations under
the Exchange Act. We did not maintain effective controls over the presentation
of our consolidated financial statements and related disclosures in preparing
our consolidated financial statements. Furthermore,
in reviewing our 10-KSB after its filing, we determined that certain information
required to be included in the Form 10-KSB was in error, including the
calculation and presentation of basic and diluted earnings (loss) per common
share, resulting in the filing of an amended annual report on Form 10-KSB/A
on
April 24, 2008. However, beginning
during the first quarter of 2008 and continuing through the date of this filing,
we have been implementing changes approved by the Audit Committee of our Board
of Directors, including hiring a new Chief Financial Officer and other personnel
with appropriate knowledge of GAAP and the financial reporting requirements
of
the Exchange Act and the ability to institute appropriate accounting and
financial statement review procedures. Except as set forth above, there were
no
significant changes in our internal control over financial reporting between
the
aforementioned evaluation and the end of the most recent fiscal quarter that
have materially affected, or are reasonably likely to materially affect, our
internal control over financial reporting. Although no system of controls can
provide absolute assurance that all control issues, if any, have been detected,
as a result of the changes set forth above, we now believe that our system
of
disclosure controls is operating effectively.
20
SAFESTITCH
MEDICAL, INC.
PART
II. OTHER INFORMATION
There
have been no material changes to legal proceedings since the filing of our
annual report on Form 10-KSB, as amended, for the year ended December 31,
2007.
Item
1A. Risk Factors.
There
have been no material changes in our risk factors since the filing of our annual
report on Form 10-KSB, as amended, for the year ended December 31,
2007.
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds.
The
information required by this Item 2 has been previously reported on our Current
Report on Form 8-K, filed with the SEC on May 29, 2008.
Item
3. Defaults upon Senior Securities.
None.
Item
4. Submission of Matters to a Vote of Security Holders.
None.
Item
5. Other Information.
None.
Item
6. Exhibits.
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|
|
|
|
Exhibits:
|
|
|
|
31.1
|
|
Certification
of Chief Executive Officer pursuant to Rule
13a-14(a)/15d-14(a)
|
|
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31.2
|
|
Certification
of Chief Financial Officer pursuant to Rule
13a-14(a)/15d-14(a)
|
|
|
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32.1
|
|
Certification
of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002
|
|
|
|
32.2
|
|
Certification
of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002
|
21
SAFESTITCH
MEDICAL,
INC.
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.
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SAFESTITCH
MEDICAL, INC.
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|||
Date:
August 8, 2008
|
By:
|
/s/
Jeffrey G. Spragens
|
|
|
|
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Jeffrey
G. Spragens
|
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President
and Chief Executive Officer
|
|
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||||
Date:
August 8, 2008
|
By:
|
/s/
Adam S. Jackson
|
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Adam
S. Jackson
|
|
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|
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Chief
Financial Officer
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22