SafeStitch Medical, Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
10-KSB/A
(Amendment No. 1)
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(Mark One) |
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Annual report pursuant to Section 13 or 15 (d) of the Securities Exchange Act of 1934 |
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For the fiscal year ended December 31, 2007 |
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OR
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Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
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For the transition period from ___to ___ |
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Commission File Number
0-19437
SAFESTITCH
MEDICAL, INC.
(formerly CELLULAR TECHNICAL SERVICES COMPANY, INC.)
(Name of Small Business Issuer as Specified in Its Charter)
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Delaware
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11-2962080 |
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(State or Other Jurisdiction of
Incorporation or Organization)
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(I.R.S. Employer Identification No.) |
4400
Biscayne Blvd. Suite 670 Miami, Florida, 33137
(Address of Principal Executive Offices) (Zip Code)
Issuers Telephone Number, Including Area Code: (305) 575-6000
Securities registered under Section 12(b) of the Exchange Act: None
Securities registered under Section 12(g) of the Exchange Act:
Common Stock, $0.001 par value per share
(Title of Class)
Check whether the issuer is not required to file reports pursuant to Section 13 or
15(d) of the Exchange Act
o
Check whether the Registrant (1) has filed all reports required to be filed by Section
13 or 15(d) of the Exchange Act during the past 12 months (or for such shorter period that
the registrant was required to file such reports), and (2) has been subject to the filing
requirements for the past 90 days.
Yes x No o
Check if there is no disclosure of delinquent filers in response to Item 405 of
Regulation S-B contained herein in any form, and, no disclosure will be contained, to the
best of Registrants knowledge, in definitive proxy or information statements incorporated
by reference in Part III of this Form 10-KSB or any amendment to this Form 10-KSB
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Indicate by check mark whether the Registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act)
Yes o No x
The Issuer had no revenue for the fiscal year ended December 31, 2007
The aggregate market value of the Registrants common stock, par value $0.001 per
share, held by non-affiliates is approximately $13,278,656, based upon the February 6, 2008
closing price of $3.95 per share as reported on the over-the-counter bulletin board.
As of
March 20, 2008 there were 16,093,016 shares of Common Stock, $0.001 par value outstanding.
Transitional Small Business Disclosure Format
Yes o No x
SAFESTITCH MEDICAL, INC.
TABLE OF CONTENTS FOR FORM 10-KSB/A
2
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This Amendment No. 1 to our
Annual Report on Form 10-KSB/A 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 activities or results to differ materially from the
activities and results anticipated in forward-looking statements. These factors include those set
forth below as well as those contained in Item 1A Risk Factors of our Annual Report on Form
10-KSB filed with the Securities and Exchange Commission on March 26, 2008. We do not undertake any obligation to update forward-looking statements. We intend that all
forward-looking statements be subject to the safeharbor provisions of 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.
Risks and uncertainties, the occurrence of which could adversely affect our business, include
the following:
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We have a history of operating losses and we do not expect to become profitable in the
near future. |
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Our technologies are in an early stage of development and are unproven. |
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Our research and development activities may not result in commercially viable products. |
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We are highly dependent on the success of our product candidates, and we cannot give
any assurance that they will receive regulatory clearance, or approval, if necessary,
or be successfully commercialized. |
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The results of previous clinical experience with devices similar to the devices that
we have licensed may not be predictive of results with our licensed products, and any
clinical trials that the U.S. Food and Drug Administration (the FDA) may require us
to undertake may not satisfy FDA requirements or the requirements of other non-U.S.
regulatory authorities. |
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We will require substantial additional funding, which may not be available to us on
acceptable terms, or at all. |
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If our competitors develop and market products that are more effective, safer or less
expensive than our future product candidates, our commercial opportunities will be
negatively impacted. |
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Our product development activities could be delayed or stopped. |
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The regulatory clearance or approval process is expensive, time-consuming and
uncertain and may prevent us or our collaboration partners from obtaining clearance,
or approval, if necessary, for the commercialization of some or all of our product
candidates. |
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Even if we obtain regulatory clearances or approvals for our product candidates, the
terms thereof and ongoing regulation of our products may limit how we manufacture and
market our product candidates, which could materially impair our ability to generate
anticipated revenues. |
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Even if we receive regulatory clearances or approvals to market our product
candidates, the market may not be receptive to our products. |
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If we fail to attract and retain key management and scientific personnel, we may be
unable to successfully develop or commercialize our product candidates. |
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As we evolve from a company primarily involved in development to a company also involved
in commercialization, we may encounter difficulties in managing our growth and expanding
our operations successfully. |
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If we fail to acquire and develop other products or product candidates at all or on
commercially reasonable terms, we may be unable to diversify or grow our business. |
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We will rely on third parties to manufacture and supply our product candidates. |
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We currently do not have a marketing staff or sales or distribution organization. If we
are unable to develop our sales and marketing and distribution capability on our own or
through collaborations with marketing partners, we will not be successful in
commercializing our product candidates. |
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Independent clinical investigators and contract research organizations that we engage to
conduct our clinical trials may not be diligent, careful or timely. |
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The success of our business may be dependent on the actions of our collaborative partners. |
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All of our current product plans are licensed to us by Creighton University. Any loss of
our rights under the agreement with Creighton University or any failure by Creighton
University to properly maintain or enforce the patents under such licenses would
materially adversely affect our business prospects. |
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An inability to find additional or other sources for our products could materially and
adversely affect us. |
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If we or Creighton University are unable to obtain and enforce patent protection for our
product candidates, our business could be materially harmed. |
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If we or Creighton University are unable to protect the confidentiality of our
proprietary information and know-how, the value of our technology and products could be
adversely affected. |
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Our commercial success depends significantly on our ability to operate without infringing
the patents and other proprietary rights of third parties. |
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Future legislative or regulatory reform of the health care system may affect our ability
to sell our products profitably. |
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Failure to obtain regulatory clearance or approval outside the United States will prevent
us from marketing our product candidates abroad. |
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Non-U.S. governments often impose strict price controls, which may adversely affect our
future profitability. |
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Our business may become subject to economic, political, regulatory and other risks
associated with international operations. |
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The market price of our common stock may fluctuate significantly. |
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Trading of our common stock is limited and trading restrictions imposed on us by
applicable regulations and by lockup agreements we have entered into with our principal
stockholders may further reduce our trading, making it difficult for our stockholders to
sell their shares. |
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Because our common stock may be a penny stock, it may be more difficult for investors
to sell shares of our common stock, and the market price of our common stock may be
adversely affected. |
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Directors, executive officers, principal stockholders and affiliated entities own a
significant percentage of our capital stock, and they may make decisions that you do not
consider to be in your best interests or in the best interests of our stockholders. |
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Compliance with changing regulations concerning corporate governance and public
disclosure may result in additional expenses. |
* * * * *
The Company files its periodic reports with the U.S. Securities and Exchange Commission (the
SEC) in compliance with the small business issuer provisions of Regulation S-B promulgated
under the Exchange Act. Generally, a small business issuer cannot file under Regulation S-B if its
annual revenues or public float exceed $25.0 million for two consecutive years. Because neither the
Companys annual revenues or public float exceeded $25.0 million for the fiscal years ended
December 31, 2006 and 2007, the Company qualifies as a Regulation S-B filer. Regulation S-B is
tailored for the small business issuer, and although it requires accurate and complete disclosure,
it does not require certain specific disclosures which are required under Regulation S-K and
Regulation S-X.
Explanatory Note
SafeStitch Medical, Inc. (the Company) is filing this Amendment No. 1 (this Amendment No.
1) to its Annual Report on Form 10-KSB for the fiscal year ended December 31, 2007, which was
originally filed on March 26, 2008 (the Original Filing). This Amendment No. 1 is being filed
solely to amend Items 7 and 8A(T) of Part II of the Original Filing. The corrections to Item 7 had no impact on
the Companys Assets, Liabilities, Stockholders
Equity, Net Loss, Operating Cash Flows or Net Cash Flows as of and for the years ended December 31,
2007 and 2006 and the for the period from September 15, 2005 (inception) through December 31, 2007
as reported in the Original Filing. The changes to Item 7 include
the following corrections:
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the Consolidated Statements of Operations for the years ended December 31, 2007 and
2006, in which we have corrected the weighted average shares outstanding and
corresponding basic and diluted net loss per share calculations for the years ended
December 31, 2007 and 2006. This Amendment No. 1 corrects basic and diluted net loss
per share for the years ended December 31, 2007 and 2006 to $(0.24) and $(0.09),
respectively, from $(0.19) and $(0.07) as reported in the Original Filing; |
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the Consolidated Statements of Cash Flows for the years ended December 31, 2007 and
2006 and the for the period from September 15, 2005 (inception) through December 31,
2007 (where certain cash flows have been reclassified as financing activities instead
of investing activities); and |
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the Notes to Consolidated Financial Statements (where we have (i) expanded Note L
to disclose the portion of our net operating losses that are deferred under Section
195 of the Internal Revenue Code of 1986, as amended, to delete the tabular references
to Research and development credit carryforward, and to correct the
proforma disclosures of the deferred tax asset as if SafeStitch LLC was a C-Corp from
inception, and (ii) added Note O to quantify the effect of these corrections to the
aforementioned Financial Statements). |
In
addition, in the Consolidated Balance Sheet as of December 31, 2007, we have a
corrected a rounding error to the entry Total Other Assets so that it now reads
1,758 instead of 1,759 as set forth in the
Original Filing. In light of the errors cited above, we have
reconsidered the effectiveness of our controls and procedures at December 31, 2007 and have amended
Item 8A(T) of Part II of the Original Filing to address this reconsideration.
Pursuant to Rule 12b-15 under the Securities Exchange Act of 1934, as amended (the Exchange
Act), this Amendment No. 1 amends the aforementioned items in their entirety and contains new
certifications pursuant to Rules 13a-14 and 15d-14 under the Exchange Act and Section 302 of the
Sarbanes-Oxley Act of 2002. Other than as set forth above and the inclusion of new certifications
pursuant to Rules 13a-14 and 15d-14 under the Exchange Act and Section 302 of the Sarbanes-Oxley
Act of 2002, no other changes or amendments to the Original Filing are being made.
Except for the amendments described above, this Form 10-KSB/A does not modify or update other
disclosures in, or exhibits to, the Original Filing. This Amendment No. 1 contains only the
sections and exhibits to the Original Filing that are being amended, and those unaffected parts or
exhibits are not included in this Amendment No. 1. This Amendment No. 1 continues to speak as of
the date of the Original Filing and the Company has not updated the disclosure contained herein to
reflect events that have occurred since the date of the Original Filing. Accordingly, this
Amendment No. 1 should be read in conjunction with the Companys other filings made with the
Securities and Exchange Commission, and is subject to updating and supplementing as provided in the
periodic reports that the Company has filed and will file after the date of the Original Filing
with the Securities and Exchange Commission.
5
Item 7. Financial Statements
The following financial statements of SafeStitch Medical, Inc. are included as required to be
filed by Item 7 of Regulation S-B, under the Exchange Act.
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Report of Independent Registered Public Accounting Firm |
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7 |
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Consolidated Balance Sheet at December 31, 2007 |
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8 |
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Consolidated Statements of Operations for the years ended December 31,
2007 and 2006 and for the period from September 15, 2005 (inception)
through December 31, 2007 |
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9 |
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Consolidated Statements of Stockholders Equity for the period from
September 15, 2005 (inception) through December 31, 2007 |
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10 |
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Consolidated Statements of Cash Flows for the years ended December 31,
2007 and 2006 and for the period from September 15, 2005 (inception)
through December 31, 2007 |
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11 |
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Notes to Consolidated Financial Statements |
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12 |
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Safestitch
LLC |
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21 |
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Report of Independent Registered Public Accounting Firm |
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22 |
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Balance Sheets as of December 31, 2006 and 2005 |
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23 |
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Statements of Operations for the year ended December 31, 2006 and for
the period from September 15, 2005 (Inception) to December 31, 2005 |
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24 |
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Statements of Members Equity for the year ended December 31, 2006 and
for the period from September 15, 2005 (Inception) to December 31,
2005 |
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25 |
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Statements of Cash Flows for the year ended December 31, 2006 and for
the period from September 15, 2005 (Inception) to December 31, 2005 |
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26 |
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Notes to Financial Statements |
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27 |
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6
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Board of Directors and Stockholders
SafeStitch Medical, Inc
We have audited the accompanying consolidated balance sheet of SafeStitch Medical, Inc.
(formerly known as Cellular Technical Services Company, Inc.)(a development stage company) (the
Company) as of December 31, 2007, and the related statements of operations, stockholders equity,
and cash flows for the years ended December 31, 2007 and 2006 and for the period from September 15,
2005 (inception) through December 31, 2007. These financial statements are the responsibility of
the Companys management. Our responsibility is to express an opinion on these financial statements
based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting
Oversight Board (United States). Those standards require that we plan and perform the audit to
obtain reasonable assurance about whether the financial statements are free of material
misstatement. We were not engaged to perform an audit of the Companys internal control over
financial reporting. Our audits include consideration of internal control over financial reporting
as a basis for designing audit procedures that are appropriate in the circumstances, but not for
the purpose of expressing an opinion on the effectiveness of the Companys internal control over
financial reporting. Accordingly, we express no such opinion. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in the financial statements. An audit
also includes assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall financial statement presentation. We believe that our
audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in all material
respects, the consolidated financial position of the Company as of December 31, 2007 and the
consolidated results of their operations and cash flows for years ended December 31, 2007 and 2006
and for the period from September 15, 2005 (inception) through December 31, 2007, in conformity
with accounting principles generally accepted in the United States of America.
/s/ Eisner LLP
New York, New York
March 26, 2008
Except for Note O, as to which the date
is April 24, 2008
7
SAFESTITCH MEDICAL, INC.
(A Developmental Stage Company)
CONSOLIDATED BALANCE SHEET
(in 000s, except share and per share data)
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December 31, |
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2007 |
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CURRENT ASSETS |
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Cash and cash equivalents |
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$ |
631 |
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Prepaid Expenses |
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99 |
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Total Current Assets |
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730 |
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FIXED ASSETS |
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Property and equipment, net |
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196 |
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OTHER ASSETS |
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Security Deposits |
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56 |
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Deferred Finance Cost |
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1,702 |
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Total Other Assets |
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1,758 |
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LONG-TERM INVESTMENT, net of valuation adjustment of $1,754 |
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0 |
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TOTAL ASSETS |
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$ |
2,684 |
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CURRENT LIABILITIES |
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Accounts payable and accrued liabilities |
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$ |
253 |
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Total Current Liabilities |
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253 |
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Shareholder Loans |
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10 |
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Commitments
and contingencies (Note I) |
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STOCKHOLDERS EQUITY |
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Preferred
Stock, $.01 par value per share, 25,000,000
shares authorized, none issued and outstanding (effective
January 8, 2008) |
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0 |
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Common
Stock, $.001 par value per share, 225,000,000
shares authorized, 16,093,016 shares issued and
outstanding (effective January 8, 2008) |
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16 |
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Additional Paid-in Capital |
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6,582 |
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Deficit accumulated during the development stage |
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(4,177 |
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Total Stockholders Equity |
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2,421 |
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TOTAL LIABILITIES AND STOCKHOLDERS EQUITY |
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$ |
2,684 |
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The accompanying notes are an integral part of these consolidated financial statements.
8
SAFESTITCH MEDICAL, INC.
(A Developmental Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS
(in 000s, except share and per share amounts)
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September 15, 2005 |
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Year Ended |
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(Inception) to |
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December 31, |
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December 31, 2007 |
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2007 |
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2006 |
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(restated) |
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(restated) |
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(Note O) |
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REVENUES |
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COSTS AND EXPENSES |
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Research & Development |
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$ |
1,636 |
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$ |
739 |
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$ |
2,451 |
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General and administrative |
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1,135 |
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340 |
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1,475 |
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Total Costs and Expenses |
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2,771 |
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1,079 |
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3,926 |
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LOSS FROM OPERATIONS |
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(2,771 |
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(1,079 |
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(3,926 |
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OTHER INCOME (NET) |
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INTEREST INCOME |
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34 |
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19 |
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53 |
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AMORTIZATION OF FINANCE COSTS |
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(283 |
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(283 |
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INTEREST EXPENSE |
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(21 |
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(21 |
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NET LOSS |
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$ |
(3,041 |
) |
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$ |
(1,060 |
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$ |
(4,177 |
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BASIC AND
DILUTED PER SHARE DATA: |
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NET LOSS |
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$ |
(0.24 |
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$ |
(0.09 |
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WEIGHTED AVERAGE SHARES OUTSTANDING: |
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12,767,000 |
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11,256,000 |
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The accompanying notes are an integral part of these consolidated financial statements.
9
SAFESTITCH MEDICAL, INC.
(A Developmental Stage
Company)
Statement of Stockholders Equity for the period September 15, 2005 (inception) through December 31, 2007
(in 000s)
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Additional |
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Deficit Accumulated |
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Preferred Stock |
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Common Stock |
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Paid-In |
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During the |
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Shares |
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Amount |
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Shares |
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Amount |
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|
Capital |
|
|
Development 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 |
|
|
|
0 |
|
|
|
35 |
|
|
|
|
|
|
|
35 |
|
Stock-Based
Compensation-September 4, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
77 |
|
|
|
|
|
|
|
77 |
|
Issuance 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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
10
SAFESTITCH MEDICAL, INC.
(A Developmental Stage Company)
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in 000s)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 15, 2005 |
|
|
|
|
|
|
|
|
|
|
|
(Inception) to |
|
|
|
Year Ended |
|
|
December 31, 2007 |
|
|
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
(restated) |
|
|
|
|
|
(restated) |
|
|
|
(Note O) |
|
|
|
|
|
(Note O) |
|
OPERATING ACTIVITIES |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(3,041 |
) |
|
$ |
(1,060 |
) |
|
$ |
(4,177 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments to reconcile net loss to net cash used in
operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of Deferred Finance Costs |
|
|
283 |
|
|
|
|
|
|
|
283 |
|
Stock-Based Compensation Expense |
|
|
142 |
|
|
|
|
|
|
|
142 |
|
Depreciation |
|
|
4 |
|
|
|
|
|
|
|
4 |
|
(Increase) in other current assets |
|
|
(79 |
) |
|
|
|
|
|
|
(79 |
) |
(Increase) in other assets |
|
|
(56 |
) |
|
|
|
|
|
|
(56 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase (Decrease) in accounts payable and accrued liabilities |
|
|
(199 |
) |
|
|
153 |
|
|
|
(32 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET CASH USED IN OPERATING ACTIVITIES |
|
|
(2,946 |
) |
|
|
(907 |
) |
|
|
(3,915 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES |
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of equipment |
|
|
(200 |
) |
|
|
|
|
|
|
(200 |
) |
Payment received under Rule 16b |
|
|
4 |
|
|
|
|
|
|
|
4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET CASH PROVIDED BY INVESTING ACTIVITIES |
|
|
(196 |
) |
|
|
0 |
|
|
|
(196 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided in connection with the acquisition of
SafeStitch LLC |
|
|
3,192 |
|
|
|
|
|
|
|
3,192 |
|
Capital Contributions |
|
|
|
|
|
|
1,430 |
|
|
|
1,431 |
|
Shareholders Loans |
|
|
|
|
|
|
|
|
|
|
84 |
|
Exercise of Options |
|
|
35 |
|
|
|
|
|
|
|
35 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET CASH PROVIDED BY FINANCING ACTIVITIES |
|
|
3,227 |
|
|
|
1,430 |
|
|
|
4,742 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET INCREASE IN CASH AND CASH EQUIVALENTS |
|
|
85 |
|
|
|
523 |
|
|
|
631 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR |
|
|
546 |
|
|
|
23 |
|
|
|
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS AT END OF YEAR |
|
$ |
631 |
|
|
$ |
546 |
|
|
$ |
631 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of non cash activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholder loan contributed to capital |
|
$ |
74 |
|
|
|
|
|
|
$ |
74 |
|
The accompanying notes are an integral part of these consolidated financial statements.
11
SAFESTITCH MEDICAL, INC.
(A Developmental Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE A BASIS OF PRESENTATION AND LIQUIDITY:
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
with SafeStitch LLC (SafeStitch) a limited liability company formed in Virginia on September 15,
2005. On September 4, 2007, Cellular acquired all of the members equity of SafeStitch in exchange
for 11,256,369 shares of its common stock, which represented a majority of outstanding shares after
the date of acquisition. For accounting purposes, the acquisition has been treated as a
recapitalization of SafeStitch, with SafeStitch as the acquirer (reverse acquisition). The
historical financial statements prior to September 4, 2007 are those of SafeStitch, 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. (Medical or the Company)
The
Company is a developmental stage medical device company focused on the development of
medical devices that manipulate tissues for obesity, gastroesophageal reflux disease (GERD),
Barretts Esophagus, esophageal obstructions, upper gastrointestinal bleeding, hernia formation and
other intraperitoneal abnormalities through endoscopic and minimally invasive surgery.
The accompanying financial statements have been prepared assuming that it will continue as a
going concern. For the period from September 15, 2005 (inception) through December 31, 2007, the
Company has accumulated a deficit of $4,177,000 and has not generated positive cash flows from
operations. The Company has been dependent upon equity financing and advances from stockholders to
meet its obligations and sustain operations. The Companys efforts had been principally devoted to
the development of its technologies and commercializing its products. Management believes that
based upon its current cash position, its budget for its business operations through December 31,
2008, an outstanding line of credit of $4.0 million from The Frost Group LLC and the Companys
President and CEO, Jeffrey G. Spragens and monitoring its discretionary expenditures; the Company
will be able to continue operations through December 31, 2008. The Companys 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.
NOTE B SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES:
[1] Consolidation:
The consolidated financial statements include the accounts of the Company and its subsidiaries
Isis Tele-Communications, Inc. and SafeStitch LLC. All inter-company accounts and transactions have
been eliminated in consolidation.
[2] Cash and cash equivalents:
We consider all highly liquid investments purchased with an original maturity of three months
or less to be cash equivalents.
[3] 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 the
assets are expensed.
12
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.
[4] Research and development:
Substantially all research and development activities are outsourced (see Note J). Research
and development costs represent principally clinical trials and manufacturing development expenses,
which are charged to expense as incurred.
[5] Patent costs:
Costs incurred in connection with acquiring patent rights and the protection of proprietary
technologies are charged to expense as incurred.
[6] 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.
[7] Stock-based compensation:
Commencing January 1, 2006, Medical has adopted 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.
[8] Fair value of financial instruments:
The carrying amounts of cash, accounts payable, and accrued expenses approximate fair value
based on their short-term maturity. Shareholder loans are carried at cost since these are related
parties.
[9] Long-Term Investment
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 for possible impairment
whenever events of 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.
[10] 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 No. 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 Companys 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.
13
[11] 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 Companys comprehensive net loss is equal to its net
loss for all periods presented.
NOTE C PROPERTY AND EQUIPMENT:
Machinery and equipment consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
December 31, 2007 |
|
Estimated Useful lives |
Machinery and equipment
|
|
|
160 |
|
|
5 years |
Furniture and fixtures
|
|
|
40 |
|
|
5 years |
|
|
|
00 |
|
|
|
Accumulated depreciation and amortization
|
|
|
(4 |
) |
|
|
|
|
|
|
|
|
|
|
|
$ |
196 |
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization expense for the years ended December 31, 2007 and 2006 was $
4 and $ 0, respectively.
NOTE D
LONG TERM INVESTMENT:
In November 1999, the Company invested in a one-year, $1.0 million 10% convertible note of
KSI, Inc. (KSI). The Company also received warrants to purchase KSI common stock in connection
with this investment. All of the outstanding stock of KSI was acquired by TruePosition, Inc., a
majority owned subsidiary of Liberty Media Corporation, (Liberty Media) in August 2000. Prior to
the acquisition, the convertible note was exchanged for KSI common stock. The Company exercised
warrants and purchased additional KSI common stock for approximately $754,000. The Companys
investment in KSI common stock was exchanged for TruePosition common stock on the date of the
acquisition. The Company accounts for the investment in TruePosition using the cost method. In
December 2002 the Company 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, the Company concluded there had been an other-than-temporary
decline in 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 current
fair value of the Companys investment in the net equity of TruePosition. TruePositions
operations have required significant infusions of cash by Liberty Media to date, and have not
generated significant revenues. The Companys investment in TruePosition common stock has been
diluted by these advances, which were converted to preferred stock in late 2002. It is possible
that in the future the Company may receive proceeds from sale of this investment, but no such
amount can be estimated at this time.
NOTE E STOCK BASED PAYMENTS:
Medicals 1996 Stock Option Plan authorizes the grant of both incentive (ISO) and
non-qualified stock options up to a maximum of 335,000 shares of Medicals Common Stock to
employees (including officers and directors who are employees) of and consultants to Medical. The
exercise price, term and vesting provision of each option grant is fixed by the Compensation
Committee with the provision that the exercise price of an ISO may not be less than the fair market
value of Medicals Common Stock on the date of grant, and the term of an ISO may not exceed ten
years. Medical has not granted any options under this plan during the years ended December 31,
2007 and 2006. The plan expired and no new options may be granted under the plan.
As of the date of the share exchange, all options issued to former officers and directors,
with exercise prices in excess of the current share price were cancelled in exchange for the
issuance of 2,000 shares per person, or, in total, 6,000 shares of common stock of the Company.
The Company recognized compensation expense of $77,000 for the fair value of the shares vested.
14
On November 13, 2007, the Board of Directors and a majority of the stockholders of the Company
approved the SafeStitch Medical Inc., 2007 Incentive Compensation Plan (the 2007 Plan). Under the
2007 Plan, which is administered by a compensation committee, the Company is allowed to grant
options, stock appreciation
rights, restricted or deferred stock grants employees, officers, directors, consultants and
vendors to purchase up to 2,000,000 shares of the Companys common stock, fully reserved for future
issuance. The exercise price of options or stock appreciation rights may not be less then fair
market value of Companys share at the date of grant and within any 12 months period, no person can
receive options or stock appreciation rights for more then one million shares. Additionally, no
stock options or stock appreciation rights granted under the plan may have a term exceeding ten
years.
No tax benefits were attributed to the stock-based compensation expense because a valuation
allowance was maintained for substantially all net deferred tax assets. We elected to adopt the
alternative method of calculating the historical pool of windfall tax benefits as permitted by FASB
Staff Position (FSP) No. SFAS 123R-3, Transition Election Related to Accounting for the Tax
Effects of Share-Based Payment Awards. This is a simplified method to determine the pool of
windfall tax benefits that is used in determining the tax effects of stock compensation in the
results of operations and cash flow reporting for awards that were outstanding as of the adoption
of SFAS 123R.
The following summarizes the activity of the Medicals stock options for the year ended
December 31, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
Aggregate |
|
|
|
Shares |
|
|
Weighted Average |
|
|
Remaining |
|
|
Intrinsic |
|
|
|
(in 000s) |
|
|
Exercise Price |
|
|
Contractual Term |
|
|
Value |
|
Outstanding at January 1, 2007 |
|
|
173 |
|
|
$ |
6.20 |
|
|
|
4.75 |
|
|
|
|
|
Granted |
|
|
89 |
|
|
|
2.60 |
|
|
|
9.95 |
|
|
|
|
|
Exercised |
|
|
(42 |
) |
|
|
0.79 |
|
|
|
|
|
|
|
|
|
Canceled or expired |
|
|
(131 |
) |
|
|
7.96 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2007 |
|
|
89 |
|
|
$ |
2.60 |
|
|
|
9.96 |
|
|
$ |
177,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at December 31, 2007 |
|
|
22 |
|
|
$ |
2.60 |
|
|
|
9.96 |
|
|
$ |
59,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and expected to vest at
December 31, 2007 |
|
|
59 |
|
|
$ |
2.60 |
|
|
|
9.96 |
|
|
$ |
118,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Company granted 88,667 options, outside of plans, during the year ended December 31, 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 $195,954 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. Stock option compensation expense was $66,000
for the year and is included in general and administrative expense.
Of the 88,667 options granted outside of plans during our 2007 fiscal year, 25% of such
options were vested as of December 31, 2007. A summary of the status of the Companys nonvested
options and changes during the year ended December 31, 2007 is presented below.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
|
|
|
Grant Date Fair |
|
|
Stock Options (in 000s) |
|
Value |
Non-Vested at January 1, 2007
|
|
|
0 |
|
|
$ |
|
|
Options Granted
|
|
|
89 |
|
|
$ |
2.21 |
|
Options Vested |
|
|
22 |
|
|
$ |
2.21 |
|
Non-Vested at December 31, 2007
|
|
|
67 |
|
|
$ |
2.21 |
|
At December 31, 2007, there was $130,000 of total unrecognized compensation cost related to
non-vested employee and director share-based compensation arrangements granted under the Plan. That
cost is expected to be recognized over a weighted-average period of 2.66 years.
The weighted-average fair values at date of grant for options granted during the year ended
December 31, 2007 were $2.21.
15
The intrinsic value of options exercised during the year ended December 31, 2007 was $77,000.
NOTE F CREDIT FACILITY:
In connection with the acquisition of SafeStitch, Medical entered into a Note and Security
Agreement with both The Frost Group, LLC, a Florida limited liability company whose members include
Frost Gamma Investments Trust, a trust indirectly controlled by Dr. Phillip Frost, the largest
beneficial holder of the issued and outstanding shares of common stock of Medical, as well as Dr.
Jane H. Hsiao and Steven D. Rubin, two of the Companys directors, and Jeffrey G. Spragens, Medical
Chief Executive Officer and President and a director for $4 million in total available borrowings,
$3.9 million from The Frost Group, LLC and $100,000 from Mr. Spragens. The credit facility has been
granted for 28 months and bears interest on outstanding borrowings under the line of credit at a
10% annual rate.
The Company granted a security interest in all presently existing and hereafter acquired or
arising 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.).
As a part of the credit facility arrangements, Medical granted warrants to purchase 805,521
shares of our common stock to The Frost Group, LLC and Mr. Spragens. The fair value of the warrants
were determined to be $1,984,691 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 values of the warrants were recorded as
deferred financing cost and will be amortized over the life of the credit facility. Amortization
expenses of deferred financing cost were $283,083 for the year ended December 31, 2007.
NOTE G CAPITAL TRANSACTIONS:
As described in Note A, on September 4, 2007, Medical acquired all of the members equity of
SafeStitch in exchange for the issuance of 11,256,369 shares of its common stock. For accounting
purposes the transaction has been treated as a recapitalization of SafeStitch and all membership
interests of SafeStitch were eliminated, ordinary shares received in exchange were recorded at par
value and the difference between membership interest and the value of the ordinary shares received
was recorded to additional paid-in capital to effect 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 incurred
$155,855 of transaction expenses, which were recorded as a reduction of additional paid-in capital.
NOTE H
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 year ended December 31,
2007 and 2006, no adjustment has been made to the weighted average outstanding common shares as the
assumed exercise of outstanding options and warrants is anti-dilutive.
Potential common shares not included in calculating diluted net loss per share are as follows
(in 000s):
|
|
|
|
|
|
|
|
|
|
|
December 31, 2007 |
|
December 31, 2006 |
Stock options
|
|
|
89 |
|
|
|
173 |
|
Stock warrants
|
|
|
806 |
|
|
|
0 |
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
895 |
|
|
|
173 |
|
|
|
|
|
|
|
|
|
|
16
NOTE I COMMITMENTS AND CONTINGENCIES
The Company is obligated under various operating lease agreements for office space.
Generally, the lease agreements require the payment of base rents plus escalations for increases in
building operating costs and real estate taxes. Rental expense under operating leases amounted to
$23,675 and $4,145 for the years ended December 31, 2007 and December 31, 2006, respectively.
At December 31, 2007, the Company was obligated under non-cancellable operating leases to make
future minimum lease payments as follows:
|
|
|
|
|
Year Ending December 31, |
|
|
|
|
2008
|
|
$ |
119,747 |
|
2009
|
|
|
99,763 |
|
2010
|
|
|
99,763 |
|
2011
|
|
|
99,763 |
|
2012
|
|
|
99,761 |
|
Thereafter
|
|
|
0 |
|
|
|
|
|
|
|
|
$ |
518,797 |
|
|
|
|
|
|
We are presently a plaintiff in a securities fraud and appraisal action in respect of our
ownership of 191,118 shares of common stock of True Position, Inc., a Delaware corporation
(referred to as True Position). This action was filed November 13, 2007 in the United States
District Court for the District of Connecticut, and we and other plaintiffs party to the suit seek
damages and other relief totaling $80 million.
In August 2007, we were informed that that Liberty TP Acquisition, Inc., which held an
aggregate of no less than 90% of True Positions outstanding capital stock, was being merged into
True Position. As a result of the merger, all of the issued and outstanding shares of common stock
of True Position were cancelled, and True Positions minority stockholders, including ourselves,
became entitled to receive $3.5116 in cash in exchange for each share held. We and other minority
stockholders considered that the consideration payable in respect of our shares under the merger
was not representative of the true value of our shares of True Position stock.
We have joined with certain other minority stockholders of True Position in bringing the
aforementioned appraisal and securities fraud action, and, on August 10, 2007, we entered into a
joint shareholder litigation governance and funding agreement (referred to as the funding
agreement) with such stockholders. Under the funding agreement, we have agreed to a fund a portion
of the litigation expenses in connection with the appraisal and securities fraud action. To date,
we have contributed approximately $45,000, and we anticipate that we will be called upon to fund at
least a similar, and possibly significantly greater, amount during our 2008 fiscal year. The
extent to which we will be called upon to contribute additional funds is determined in part by the
majority vote of those stockholders party to the funding agreement. We may elect to terminate our
participation in the funding agreement upon ten days written notice to the administrative agent
under the agreement. Upon termination, we would no longer be required to fund any amounts not
already paid by us under the funding agreement, but we would lose all rights to participate under
the funding agreement, including access to any additional work-product created after the date of
termination. Additionally, if we elect to terminate our participation under the funding agreement,
our portion of any proceeds from a favorable disposition of the litigation may be reduced. The
outcome of this litigation is not now known, nor can it be reasonably predicted at this time.
NOTE J NEW ACCOUNTING PRONOUNCEMENTS
In September 2006, the Financial Accounting Standards Board (FASB) issued SFAS No. 157, Fair
Value Measurements, or SFAS 157, which defines fair value, establishes a framework for measuring
fair value and requires additional disclosures about fair value measurements. SFAS 157 is effective
for fiscal years beginning after November 15, 2007 with early adoption permitted; in November 2007,
the FASB agreed to defer the effective date
17
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. Generally, the provisions of this statement should be applied prospectively as of
the beginning of the fiscal year in which this statement is initially applied. We have determined
that the adoption of SFAS 157 will not have a material effect on our consolidated financial
statements.
In February 2007, FASB issued 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. This statement is effective for fiscal years beginning after November 15, 2007 with early
adoption permitted. We have determined that the adoption of SFAS 159 will not have a material
affect on our consolidated financial position, results of operations, cash flows or financial
statement disclosures.
In December 2007, the FASB issued FAS No. 160, Noncontrolling Interests in Consolidated
Financial Statements-an amendment of ARB No. 51. FAS No. 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. FAS No. 160 is effective for the Company in its fiscal year beginning January 1, 2009.
The Company is currently evaluating the impact of FAS No. 160 on its consolidated financial
position and results of operations.
In December 2007, the FASB issued FAS No. 141 R Business Combinations. FAS No. 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. FAS No. 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. FAS No. 141R is effective for the Company in its fiscal year beginning
January 1, 2009. While the Company has not yet evaluated this statement for the impact, if any,
that FAS No. 141R will have on its consolidated financial position and results of operations, the
Company will be required to expense costs related to any acquisitions after September 30, 2009.
NOTE K AGREEMENT WITH CREIGHTON UNIVERSITY
On May 26, 2006, SafeStitch entered into an exclusive license and development agreement with
Creighton University granting us a worldwide exclusive (even as to the university), with rights to
sublicense, license to all our product candidates and associated know-how, including the exclusive
right to manufacture, use and sell the product candidates.
During
such time as we sell any product licensed under this agreement, we are obligated to pay Creighton
University, on a quarterly basis, a royalty of 1.5% of the revenue
collected worldwide from such sales, less certain amounts, including, without
limitation, chargebacks, credits, taxes, duties and discounts or rebates. The agreement does not
provide for minimum royalties.
We have agreed to invest in the aggregate, at least $2.5 million over 36 months, beginning May
26, 2006, towards development of any licensed product, not including the first $150,000 of costs
related to the prosecution of patents, which we have done and SafeStitch has to pay to Creighton
University 20 percent of its research and development expenditures as reimbursement for use of
Creighton Universitys facilities.
Our failure to do so would have resulted in all rights in the licensed patents and know-how
reverting back to the university. Through December 31, 2007, we had invested $2,709,183 in the
licensed products, inclusive of our costs to date relating to prosecution of patents. Pursuant to
the agreement, we are entitled to exercise our own business judgment and sole and absolute
discretion over the marketing, sale, distribution, promotion or other commercial exploitation of
any licensed products, provided that if we have 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 agreement or the date such technology is disclosed to and accepted by us, then the
licensed patent and associated know-how shall revert back to the university, with no rights
retained by us, and the university will have
the right to seek a third party with whom to commercialize such patent and associated
know-how, unless we purchase one year extensions.
18
NOTE L 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 Medicals 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. As a result of the share exchange transaction on September 4, 2007 with SafeStitch, LLC
our net operating losses for Medical may be limited under Section 382 of the Internal Revenue Code
due to a more than 50% change in ownership over a three year period.
At
December 31, 2007, we have approximately $506,000 of net operating loss carryforwards to
offset future federal taxable income and a deferred tax asset of $589,000 from certain operating expenses which
have been deferred as start up costs under Sec. 195 for federal income tax purposes, subject to limitations for
alternative minimum tax.
The net operating loss carryforwards expire in 2027.
The
deferred federal tax asset, which amounted to $476,000 at December 31, 2007, has been
offset by a valuation allowance against the entire benefit due to managements uncertainty
regarding the future profitability of our Company. The valuation allowance has been increased by
$476,000 in 2007.
The difference between income taxes at the statutory federal income tax rate and income taxes
reported in the statements of operations are attributable to the following:
|
|
|
|
|
|
|
December 31, |
|
|
2007 |
Income tax benefit at the federal statutory rate
|
|
|
34.00 |
% |
State and local income taxes, net of effect on federal taxes
|
|
|
3.63 |
|
Increase in valuation allowance
|
|
|
(37.63 |
) |
|
|
|
|
|
|
|
|
|
|
Provision for income tax
|
|
|
0 |
% |
|
|
|
|
|
The deferred tax asset at December 31, 2007 consists of the following:
|
|
|
|
|
|
|
2007 |
|
Net operating loss carryforward |
|
$ |
202,000 |
|
Deferred start up costs |
|
|
221,000 |
|
Stock-based compensation |
|
|
53,000 |
|
|
|
|
|
|
|
|
476,000 |
|
Less: Valuation allowance |
|
|
(476,000 |
) |
|
|
|
|
Net deferred tax asset |
|
$ |
0 |
|
|
|
|
|
For comparative purposes, the following table shows the proforma effect as if SafeStitch was a
C-Corp from inception.
The deferred tax asset at December 31, 2007 and 2006 consists of the following:
|
|
|
|
|
|
|
|
|
|
|
2007 |
|
|
2006 |
|
|
|
Proforma |
|
|
Proforma |
|
Net operating loss carryforward |
|
$ |
923,000 |
|
|
$ |
299,000 |
|
Deferred start up costs |
|
|
649,000 |
|
|
|
128,000 |
|
|
|
|
|
|
|
|
|
|
|
1,572,000 |
|
|
|
427,000 |
|
Less: Valuation allowance |
|
|
(1,572,000 |
) |
|
|
(427,000 |
) |
|
|
|
|
|
|
|
Net deferred tax asset |
|
$ |
0 |
|
|
$ |
0 |
|
|
|
|
|
|
|
|
19
At December 31, 2006, CTS had available for federal income tax purposes, net operating loss
carryforwards of approximately $54.1 million which expire through 2026, and research and
development tax credits of approximately $1.2 million that will expire through 2024. The Company
has provided a valuation allowance of 100% of the net deferred tax asset related to the operating
loss carryforwards and tax credits. Upon consummation of the share exchange with SafeStitch LLC,
these net deferred tax assets along with net operating losses up to
September 4, 2007 were forfeited in accordance
with Section 382 of the Internal Revenue Code.
At
December 31, 2006, CTS has AMT credits of $53,000 to be utilized in future tax periods to the
extent that the regular tax exceeds the AMT liability. Under Section 383 of the Internal Revenue
Code, these AMT credits are forfeited due to change in control.
The Company adopted Financial
Standards Board Interpretation No. 48 Accounting for Uncertainty in
Income Taxes (FIN 48) an interpretation of FASB Statement 109 ("SFAS 109") on January 1, 2007.
The adoption of FIN48 did not have a material impact on our results or operations and financial position.
At the adoption date of January 1, 2007, we did not have any
unrecognized tax benefits.
Medical recognizes interest
and penalties related to uncertain tax positions in general and administrative expense. As of December 31, 2007,
the Company has not recorded any provisions for accrued interest and
penalties related to uncertain tax positions.
Tax
years 2003-2006 remain open to examination by the major taxing
jurisdictions to which we are subject.
NOTE M CONCENTRATION OF RISK
The Companys financial instruments that are exposed to concentrations of credit risk consist
primarily of cash. The Company maintains its cash at financial institutions it considers to be of
high credit quality. Cash balances with any one institution may exceed federally insured amounts.
For
the years ended December 31, 2007 and 2006, one vendor
represented approximately 43% of
Companys expenses.
NOTE N SUBSEQUENT EVENTS
On January 8, 2008, we changed our name from Cellular Technical Services Company, Inc. to
SafeStitch Medical, Inc. On the same date, we increased the aggregate number of shares of all
classes of capital stock that we may issue from 35,000,000 to 250,000,000, which is composed of
225,000,000 shares of common stock, par value $0.001 per share, and 25,000,000 shares of preferred
stock, par value $0.01 per share
On March 10, 2008, we drew down $1.0 million from our $4.0 credit facility.
On March 18, 2008, we issued an aggregate of 95,500 options to purchase our common stock under
the SafeStitch Medical, Inc. 2007 Incentive Compensation Plan, each at a strike price of $3.10 per
share. These options were issued as follows: each of our independent and non-employee directors,
Kevin Wayne, Kenneth Heithoff, Dr. Jane Hsiao, Steven Rubin and Richard Pfenniger, received 10,000
options, except that Dr. Hsiao, Mr. Rubin and Mr. Pfenniger received an additional 5,000, 1,000 and
1,000 options, respectively, for their respective service as chairman of our Board of Directors,
Compensation Committee and Audit Committee; and the remaining 33,500 options were issued to new and
existing employees and consultants, including 5,000 to Jeffrey G. Spragens, our President and Chief
Executive Officer, and 10,000 to Dr. Stewart B. Davis, our Chief Operating Officer and Secretary.
On March 24, 2008, we issued to new employees an aggregate of 53,000 options to purchase our
common stock under the SafeStitch Medical, Inc. 2007 Incentive Compensation Plan, each at a strike
price of $3.00 per share.
Our principal corporate office
is located at 4400 Biscayne Blvd, Suite 670, Miami, Florida. We rent this space from Frost Real Estate Holdings, LLC,
which is a company controlled by Dr. Phillip Frost, our largest beneficial stockholder. We lease approximately 2,900
square feet under the lease agreement, which is for a five-year term that began on January 1, 2008, and requires
annual rent of approximately $91,000, which amount increases by
approximately 4.5% per year.
NOTE O REVISIONS TO PREVIOUSLY ISSUED FINANCIAL STATEMENTS
Subsequent to the filing of the Companys Form 10-KSB for the year ended December 31, 2007,
Management, in consultation with the Companys Independent Auditors, identified a rounding error in
the Consolidated Balance Sheet as of December 31, 2007. This error resulted in a $1,000
overstatement of Total Other Assets, because $1,759,000 was reported instead of $1,758,000. This
error had no impact on reported Total Assets or Total Liabilities and
Stockholders Equity.
Management also identified an error relating to the weighted average number of common shares
outstanding disclosed in the Consolidated Statements of Operations for the years ended as of
December 31, 2007 and 2006. Basic and diluted loss per share were
calculated using the number of shares outstanding and to give effect
for the recapitalization at December 31, 2007 and 2006,
respectively, instead
of using the weighted
average number of shares outstanding during each of the years then ended.
The following table summarizes the adjustments to the Companys Consolidated Statements of
Operations for the years ended December 31, 2007 and 2006 to correct this error:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Basic and |
|
|
|
|
|
|
|
average shares |
|
|
diluted loss per |
|
|
|
Net Loss ($000) |
|
|
outstanding |
|
|
share |
|
For the year ended December 31, 2007: |
|
|
|
|
|
|
|
|
|
|
|
|
As previously reported |
|
$ |
(3,041 |
) |
|
|
16,093,000 |
|
|
$ |
(0.19 |
) |
Adjustment |
|
|
|
|
|
|
(3,326,000 |
) |
|
|
(0.05 |
) |
|
|
|
|
|
|
|
|
|
|
As restated |
|
$ |
(3,041 |
) |
|
|
12,767,000 |
|
|
$ |
(0.24 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, 2006: |
|
|
|
|
|
|
|
|
|
|
|
|
As previously reported |
|
$ |
(1,060 |
) |
|
|
16,050,000 |
|
|
$ |
(0.07 |
) |
Adjustment |
|
|
|
|
|
|
(4,794,000 |
) |
|
|
(0.02 |
) |
|
|
|
|
|
|
|
|
|
|
As restated |
|
$ |
(1,060 |
) |
|
|
11,256,000 |
|
|
$ |
(0.09 |
) |
|
|
|
|
|
|
|
|
|
|
Management also identified the misclassification of certain items in the Consolidated
Statements of Cash Flows. The cash flow associated with the merger of
SafeStitch LLC
transaction should have been classified as a financing activity. The
Companys consolidated statement of cash flows for the year
ended December 31, 2007 is unchanged. The following table summarizes
the adjustments to the Companys Consolidated Statements of Cash Flows for the years ended December
31, 2007 and for the period from September 15, 2005 (inception) through December 31, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As Previously |
|
|
|
|
|
|
|
|
|
Reported |
|
|
Adjustment |
|
|
As Restated |
|
For the year ended December 31, 2007: |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
$ |
(2,946 |
) |
|
|
|
|
|
$ |
(2,946 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash provided in connection with the acquisition of SafeStitch LLC |
|
|
3,192 |
|
|
|
(3,192 |
) |
|
|
|
|
Cash used in other investing activities |
|
|
(196 |
) |
|
|
|
|
|
|
(196 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities |
|
|
2,996 |
|
|
|
(3,192 |
) |
|
|
(196 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash provided in connection with the acquisition of SafeStitch LLC |
|
|
|
|
|
|
3,192 |
|
|
|
3,192 |
|
Cash provided by other financing activities |
|
|
35 |
|
|
|
|
|
|
|
35 |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
35 |
|
|
|
3,192 |
|
|
|
3,227 |
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash |
|
$ |
85 |
|
|
|
|
|
|
$ |
85 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 15, 2005 (inception) to December 31, 2007: |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
$ |
(3,915 |
) |
|
|
|
|
|
$ |
(3,915 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash provided in connection with the acquisition of SafeStitch LLC |
|
|
3,192 |
|
|
|
(3,192 |
) |
|
|
|
|
Cash used in other investing activities |
|
|
(196 |
) |
|
|
|
|
|
|
(196 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities |
|
|
2,996 |
|
|
|
(3,192 |
) |
|
|
(196 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash provided in connection with the acquisition of SafeStitch LLC |
|
|
|
|
|
|
3,192 |
|
|
|
3,192 |
|
Cash provided by other financing activities |
|
|
1,550 |
|
|
|
|
|
|
|
1,550 |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
1,550 |
|
|
|
3,192 |
|
|
|
4,742 |
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash |
|
$ |
631 |
|
|
|
|
|
|
$ |
631 |
|
|
|
|
|
|
|
|
|
|
|
20
SAFESTITCH LLC
(a development stage company)
FINANCIAL STATEMENTS
DECEMBER 31, 2006 and 2005
21
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Members
SafeStitch LLC
We have audited the accompanying statements of financial position of SafeStitch LLC (a development
stage company) (the Company) as of December 31, 2006 and 2005, and the related statements of
operations, changes in members equity (deficit) and cash flows for the year ended December 31,
2006, and for the periods from September 15, 2005 (inception) through December 31, 2005 and
December 31, 2006. These financial statements are the responsibility of the Companys management.
Our responsibility is to express an opinion on these financial statements based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight
Board (United States). Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material misstatement. An
audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the
financial statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall financial statement
presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in all material
respects, the financial position of SafeStitch LLC as of December 31, 2006 and 2005, and the
results of their operations and their cash flows for the year ended December 31, 2006, and for the
periods from September 15, 2005 (inception) through December 31, 2005 and December 31, 2006 in
conformity with accounting principles generally accepted in the United States of America.
/s/ Eisner
LLP
New York, New York
March 26, 2008
22
SAFESTITCH LLC
(a development stage company)
Statements of Financial Position
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
546,097 |
|
|
$ |
23,183 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
$ |
546,097 |
|
|
$ |
23,183 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND MEMBERS EQUITY (DEFICIT) |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Loan from member |
|
$ |
10,000 |
|
|
$ |
84,000 |
|
Accounts payable |
|
|
166,709 |
|
|
|
14,171 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
176,709 |
|
|
|
98,171 |
|
|
|
|
|
|
|
|
MEMBERS EQUITY (DEFICIT) |
|
|
|
|
|
|
|
|
Members contributions |
|
|
1,505,002 |
|
|
|
1,002 |
|
Deficit accumulated during development stage |
|
|
(1,135,614 |
) |
|
|
(75,990 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total members equity (deficit) |
|
|
369,388 |
|
|
|
(74,988 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
546,097 |
|
|
$ |
23,183 |
|
|
|
|
|
|
|
|
See notes to financial statements.
23
SAFESTITCH LLC
(a development stage company)
Statements of Operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 15, 2005 |
|
|
September 15, 2005 |
|
|
|
|
|
|
|
(inception) |
|
|
(inception) |
|
|
|
Year Ended |
|
|
Through |
|
|
Through |
|
|
|
December 31, 2006 |
|
|
December 31, 2005 |
|
|
December 31, 2006 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development costs |
|
$ |
738,593 |
|
|
$ |
76,068 |
|
|
$ |
814,661 |
|
General and administrative |
|
|
340,596 |
|
|
|
41 |
|
|
|
340,637 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
1,079,189 |
|
|
|
76,109 |
|
|
|
1,155,298 |
|
Other income: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
19,565 |
|
|
|
119 |
|
|
|
19,684 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(1,059,624 |
) |
|
$ |
(75,990 |
) |
|
$ |
(1,135,614 |
) |
|
|
|
|
|
|
|
|
|
|
See notes to financial statements.
24
SAFESTITCH LLC
(a development stage company)
Statements of Changes in Members Equity (Deficit)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit Accumulated |
|
|
|
|
|
|
Members |
|
|
During Development |
|
|
|
|
|
|
Contributions |
|
|
Stage |
|
|
Total |
|
Contributions November 2005 |
|
$ |
1,002 |
|
|
|
|
|
|
$ |
1,002 |
|
Net loss for the period ended
December 31, 2005 |
|
|
|
|
|
$ |
(75,990 |
) |
|
|
(75,990 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance December 31, 2005 |
|
|
1,002 |
|
|
|
(75,990 |
) |
|
|
(74,988 |
) |
Contributions February - July 2006 |
|
|
1,430,000 |
|
|
|
|
|
|
|
1,430,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loan from a member reclassifed to
members equity |
|
|
74,000 |
|
|
|
|
|
|
|
74,000 |
|
Net loss for the period ended
December 31, 2006 |
|
|
|
|
|
|
(1,059,624 |
) |
|
|
(1,059,624 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance December 31, 2006 |
|
$ |
1,505,002 |
|
|
$ |
(1,135,614 |
) |
|
$ |
369,388 |
|
|
|
|
|
|
|
|
|
|
|
See notes to financial statements.
25
SAFESTITCH LLC
(a development stage company)
Statements of Cash Flows
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 15, 2005 |
|
|
September 15, 2005 |
|
|
|
|
|
|
|
(inception) |
|
|
(inception) |
|
|
|
Year Ended |
|
|
Through |
|
|
Through |
|
|
|
December 31, 2006 |
|
|
December 31, 2005 |
|
|
December 31, 2006 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(1,059,624 |
) |
|
$ |
(75,990 |
) |
|
$ |
(1,135,614 |
) |
Adjustments to reconcile net loss
to net cash used in operating
activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Changes in: |
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable |
|
|
152,538 |
|
|
|
14,171 |
|
|
|
166,709 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating
activities |
|
|
(907,086 |
) |
|
|
(61,819 |
) |
|
|
(968,905 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Loan from member |
|
|
|
|
|
|
84,000 |
|
|
|
84,000 |
|
Contributions from members |
|
|
1,430,000 |
|
|
|
1,002 |
|
|
|
1,431,002 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by
financing activities |
|
|
1,430,000 |
|
|
|
85,002 |
|
|
|
1,515,002 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash |
|
|
522,914 |
|
|
|
23,183 |
|
|
|
546,097 |
|
Cash - beginning |
|
|
23,183 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash - end |
|
$ |
546,097 |
|
|
$ |
23,183 |
|
|
$ |
546,097 |
|
|
|
|
|
|
|
|
|
|
|
During 2006, the managing members loan of $74,000 was reclassified as a members contribution.
Interest and taxes paid during the year ended December 31, 2006 and period ended December 31, 2005
were nil.
See notes to financial statements.
26
SAFESTITCH LLC
(a development stage company)
Notes to Financial Statements
December 31, 2006 and 2005
Note A Organization and Summary of Significant Accounting Policies
SafeStitch LLC (the Company) was formed as a limited liability company pursuant to Articles
of Organization in the Office of Virginia State Corporation Commission on September 15, 2005 and
commenced operations on December 21, 2005. The Company is a development stage company that was
formed to finance, develop, market and license or sell medical devices that manipulate tissues for
obesity, gastro esophageal reflux disease (GERD), Barretts Esophagus, esophageal obstructions,
upper gastrointestinal bleeding, hernia formation and other intraperitoneal abnormalities through
endoscopic and minimally invasive surgery pursuant to the license and development agreement with
Creighton University (Note C).
Based on management plans, these financial statements have been prepared under the going
concern assumption which presumes that the Company will continue its existence.
The Company does not expect to have any current source of revenues. However, management
believes that as the result of the share exchange with CTSC (Note H), the Company will have
sufficient resources to fund its current cash flow requirements
through December 31, 2007.
[1] 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 at the date of the financial statements and the reported
amounts of revenue and expenses during the reporting period. Actual results could differ from
those estimates.
[2] Income taxes:
No provision or benefit for income taxes has been included in these financial statements
since taxable income or loss passes through to, and is reportable by, the members
individually.
[3] Cash and cash equivalents:
The Company considers all highly liquid investments with maturities of three months or
less when purchased to be cash equivalents.
[4] Research and development costs:
Research and development costs are expensed as incurred.
Note B Consultants
The Company entered into agreements with various consultants to provide consulting services
effective September 1, 2006. The consultants will receive compensation on an hourly rate for
services performed for the Company. The consultants shall also be reimbursed all reasonable
expenses incurred on behalf of the Company. The agreements had
various term dates which expired in 2007 and, in October 2007, were
renewed for one year periods. Termination of the agreements prior to the expiration can only be executed by the events stated in
the agreements. As of December 31, 2006 and 2005, consultant fees totaled $523,186 and $0 and are
included in research and development costs.
27
SAFESTITCH LLC
(a development stage company)
Notes to Financial Statements
December 31, 2006 and 2005
Note C License and Development Agreement
On May 26, 2006, the Company entered into an exclusive license and development agreement with
Creighton University granting a worldwide exclusive license, with rights to sublicense, to all our
product candidates and associated know-how, including the exclusive right to manufacture, use and
sell the product candidates. In accordance with the agreement, Creighton University is entitled to
1.5 percent of the licensed products net sales. In accordance with the license and development
agreement with Creighton University, the Company is to invest, in aggregate, at least $2,500,000
within 36 months of the execution of this agreement towards the development of the licensed
product, including reimbursement of Creighton Universitys overhead expenses, related to the
Companys use of its facilities and calculated as 20% of the Companys direct development
expenditures. If the Company fails to meet its development obligations, all rights in the licensed
patent rights and associated know-how shall revert back to Creighton University.
Note D Due to Member
As of December 31, 2005, the managing member advanced $84,000 to the Company in addition to
its initial capital contribution. During 2006, $74,000 of this advance was reclassified as a
capital contribution. The outstanding balance as of December 31,
2006 is $10,000, which will be reclassified as a capital contribution in 2008.
Note E Lease
The Company entered into a lease agreement on May 31, 2006. The lease agreement has a
two-year term which expires on May 31, 2008. The rental payments are $346 per month and are due on
the first day of each month. As of December 31, 2006, the Company paid $3,959 in rental payments
which is included in general and administrative expenses on the statement of operations.
Future minimum lease payments on the operating lease for the remainder of the lease term is:
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
2007 |
|
|
$ |
4,158 |
|
|
|
|
2008 |
|
|
$ |
1,733 |
|
Note F Concentration of Credit Risk
The Company maintains its cash balances in one bank. The balances are insured by the Federal
Deposit Insurance Corporation up to $100,000. As of December 31, 2006, the uninsured portion of
the cash balances held at the banks was $446,097.
28
SAFESTITCH LLC
(a development stage company)
Notes to Financial Statements
December 31, 2006 and 2005
Note G New Accounting Pronouncements
In September 2006, FASB issued SFAS No. 157, Fair Value Measurements (SFAS 157), which
defines fair value, establishes a framework for measuring fair value in generally accepted
accounting principles and expands disclosures about fair value measurements. This statement is
effective for financial statements issued for fiscal years beginning after November 15, 2007 and
interim periods within those fiscal years. Earlier application is encouraged provided that the
reporting entity has not yet issued financial statements for that fiscal year including financial
statements for an interim period within that fiscal year. We have determined that the adoption of
SFAS 157 will not have a material affect on our consolidated financial position, results of
operations, cash flows or financial statement disclosures.
In February 2007, FASB issued 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. This statement is effective for fiscal years beginning after November 15, 2007 with early
adoption permitted. We have determined that the adoption of SFAS 159 will not have a material
affect on our consolidated financial position, results of operations, cash flows or financial
statement disclosures.
In December 2007, the FASB issued SFAS No. 141(R), Business Combinations. This statement
replaces SFAS No. 141, Business Combinations. This statement retains the fundamental requirements
in Statement 141 that the acquisition method of accounting (which Statement 141 called the purchase
method) be used for all business combinations and for an acquirer to be identified for each
business combination. This statement also establishes principles and requirements for how the
acquirer: a) recognizes and measures in its financial statements the identifiable assets acquired,
the liabilities assumed, and any non-controlling interest in the acquiree; b) recognizes and
measures the goodwill acquired in the business combination or a gain from a bargain purchase and c)
determines what information to disclose to enable users of the financial statements to evaluate the
nature and financial effects of the business combination. SFAS No. 141(R) will apply prospectively
to business combinations for which the acquisition date is on or after Companys fiscal year
beginning January 1, 2009.
In December 2007, the FASB issued SFAS No. 160, Non-controlling Interests in Consolidated
Financial Statements. This statement amends ARB 51 to establish accounting and reporting
standards for the non-controlling (minority) interest in a subsidiary and for the deconsolidation
of a subsidiary. It clarifies that a non-controlling interest in a subsidiary is an ownership
interest in the consolidated entity that should be reported as equity in the consolidated financial
statements. The Company has not yet determined the impact, if any, that SFAS No. 160 will have on
its consolidated financial statements. SFAS No. 160 is effective for the Companys fiscal year
beginning January 1, 2009.
Note H Subsequent Events
On September 4, 2007, Cellular Technical Services Company, Inc. (CTSC), a public company,
acquired the Company pursuant to a Share Transfer, Exchange and Contribution Agreement, dated as of
July 25, 2007 (referred to as the Share Exchange Agreement). The Share Exchange Agreement
provided for the exchange of all issued and outstanding membership interests of the Company for
11,256,369 shares of CTSCs common stock (the Share Exchange).
29
Note H Subsequent Events (continued)
The Share Exchange will be accounted for as a recapitalization of the Company pursuant to the
Share Exchange Agreement. For accounting purposes, the Company is treated as the continuing
reporting entity. Because the members of the Company end up with control of CTSC, the transaction
would normally be considered a purchase by the Company. However, since CTSC is not a business, the
transaction is not a business combination. Instead the transaction is accounted for as a
recapitalization of the Company and the issuance of stock by the Company (represented by the
outstanding shares of CTSC) for the assets and liabilities of the CTSC.
In connection with the consummation of the Share Exchange, CTSC entered into a Note and
Security Agreement with a company controlled by the largest beneficial holder of CTSC and certain
of the Companys directors, and the Chief Executive Officer, President and a director, for a credit
line of up to $4 million. The loan will bear 10% interest on the outstanding balance. In
connection with entering into this line of credit, the CTSC granted warrants to purchase a total of
805,521 shares of the CTSCs common stock to the holders of the Note with an exercise price of
$.25, computed as stockholders equity of CTSC after taking into consideration all accrued and
contingent liabilities at the closing of the Share Exchange plus $1,250,000 divided by the number
of fully-diluted shares of CTSC after the Share Exchange, and having a ten-year term.
30
Item 8A(T). Controls and Procedures
The Companys management, with the participation of its Chief Executive Officer and Chief
Financial Officer, evaluated the effectiveness of the design and operation of the Companys
disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) or 15d-15(e)) as of
December 31, 2007. Based upon that evaluation, the Chief Executive Officer and Chief Financial
Officer concluded that, as of that date, the Companys disclosure controls and procedures were not
effective at a reasonable assurance level because of the identification of a material weakness in
our internal control over financial reporting. Our remediation efforts are discussed further below
under Managements Report on Internal Control over Financial Reporting.
There were no changes in the Companys internal control over financial reporting during the
last quarter that have materially affected, or are reasonably likely to materially affect, the
Companys internal control over financial reporting.
Managements Report on Internal Control over Financial Reporting
Management is responsible for establishing and maintaining adequate internal control over
financial reporting. Internal control over financial reporting is a process designed to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with generally accepted accounting
principles. Internal control over financial reporting includes those policies and procedures that:
(i) pertain to the maintenance of records that in reasonable detail accurately and fairly reflect
the transactions and dispositions of the assets of the Company; (ii) provide reasonable assurance
that transactions are recorded as necessary to permit preparation of financial statements in
accordance with generally accepted accounting principles, and that receipts and expenditures of the
Company are being made only in accordance with authorizations of management and directors of the
Company; and (iii) provide reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use, or disposition of the Companys assets that could have a material
effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent
or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are
subject to the risk that controls may become inadequate because of changes in conditions, or that
the degree of compliance with the policies or procedures may deteriorate.
For the period ended December 31, 2007, pursuant to Section 404 of the Sarbanes-Oxley Act of
2002, management (with the participation of our principal executive officer and principal financial
officer) conducted an evaluation of the effectiveness of our internal control over financial
reporting based on the framework established in Internal ControlIntegrated Framework issued by
the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Based on this
evaluation, management concluded that, as of December 31, 2007, our internal control over financial
reporting were not effective due to the material weakness disclosed below under Changes in
Internal Controls Over Financial Reporting and Managements Remediation Initiatives.
Changes in Internal Controls Over Financial Reporting and Managements Remediation Initiatives
As defined by Rule 12b-2 promulgated under the Securities Exchange Act of 1934, as amended, a
material weakness is a deficiency, or a combination of deficiencies, in internal control over
financial reporting such that there is a reasonable possibility that a material misstatement of the
registrants annual or interim financial statements will not be prevented or detected on a timely
basis.
We identified the following material weakness in our internal control over financial reporting
as we did not have adequate controls in place to establish and maintain an effective control
environment. The following deficiency in the control environment constituted a material weakness:
31
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. This weakness was evidenced during the
preparation of our Annual Report on Form 10-KSB for the fiscal year ended December 31, 2007 by the
need for significant revisions to our consolidated financial statements and related disclosures in
the notes thereto.
The corrections set forth in Item 7 to this Amendment
No. 1 to our Annual Report on Form 10-KSB/A relate directly to the material weakness described above.
Upon identification of the material weakness, management advised our Audit Committee of the
issues encountered and managements key decisions relating to remediation efforts. Under the
direction of our Chief Executive Officer and Chief Financial Officer, we developed a plan to
remediate the material weakness. Our Audit Committee reviewed, advised and concurred with
managements plan of remediation, which includes the addition of employees who are trained in the
preparation of financial statements in accordance with GAAP and who have the experience necessary
to ensure that we have in place appropriate internal control over financial reporting.
Although this material weakness over preparation of the financial statements and related
disclosures existed at year end, it has been corrected, and the consolidated financial statements
in this Amendment No. 1 to our Annual Report on Form 10-KSB/A fairly present, in all material respects, our financial
condition as of December 31, 2007 and 2006 and our results of operations and cash flows for the
years ended December 31, 2007 and 2006, in conformity with GAAP.
While we have taken appropriate steps to remediate the material weakness described above,
additional measures may be required. The effectiveness of our internal controls following our
remediation efforts will not be known until we test those controls in connection with managements
tests of internal control over financial reporting that will be performed after the close of our
first fiscal quarter of 2008, ending March 30, 2008.
This annual report does not include an attestation report of our registered public accounting
firm, Eisner LLP, regarding internal control over financial reporting. Managements report was not
subject to attestation by our registered public accounting firm pursuant to temporary rules of the
Securities and Exchange Commission that permit us to provide only managements report in this
annual report.
32
PART III
Item 13. Exhibits
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Exhibits: |
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3.1
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Restated Certificate of Incorporation of the Registrant, as amended, filed
as Annex A to our Definitive Information Statement on Schedule 14C filed
with the SEC on December 7, 2007 and incorporated by reference herein. |
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3.2*
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Amended and Restated Bylaws of SafeStitch Medical, Inc. |
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4.1*
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Specimen Certificate for Common Stock of Registrant |
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4.2
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Form of Common Stock Warrant, filed as Exhibit 4.1 to our Current Report on
Form 8-K filed with the SEC on September 10, 2007 and incorporated by
reference herein. |
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10.1+
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1996 Stock Option Plan filed with our Quarterly Report on Form 10-Q filed
with the SEC on August 8, 1995 and incorporated by reference herein. |
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10.2+
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Amendment to 1996 Stock Option Plan dated December 14, 1998, filed as
Exhibit 7.8 to our Annual Report on Form 10-K filed with the SEC on March
30, 1999 and incorporated by reference herein. |
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10.3
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Form of Lockup Agreement, filed as Exhibit 2.4 to our Current Report on Form
8-K filed with the SEC on July 31, 2007 and incorporated by reference
herein. |
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10.4
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Note and Security Agreement, dated as of September 4, 2007, by and among the
Company, SafeStitch LLC, the Frost Group, LLC and Jeffrey G. Spragens, filed
as Exhibit 10.2 to our Current Report on Form 8-K filed with the SEC on
September 10, 2007 and incorporated by reference herein. |
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10.5*
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Exclusive License and Development Agreement, dated as of May 26, 2006, by
and between Creighton University and SafeStitch LLC. |
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10.6+
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Letter Agreement for Terms of Employment between SafeStitch LLC and Stewart
B. Davis, M.D., dated May 16, 2007, filed as Exhibit 10.4 to our Current
Report on Form 8-K filed with the SEC on September 10, 2007 and incorporated
by reference herein. |
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10.7+
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SafeStitch Medical, Inc. 2007 Incentive Compensation Plan, filed as Annex B
to our Definitive Information Statement on Schedule 14C, filed with the SEC
on December 7, 2007 and incorporated by reference herein. |
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14.1
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Code of Ethics Pursuant to Section 406 of the Sarbanes-Oxley Act of 2002
filed as exhibit 14 to our Annual Report on Form 10-K filed with the SEC on
March 30, 2005 and incorporated by reference herein. |
34
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Exhibits: |
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21.1*
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Subsidiaries of the Registrant |
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23.1**
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Consent of Eisner LLP independent registered public accounting firm |
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31.1**
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Certification of Chief Executive Officer pursuant to Rule 13a-14(a)/15d-14(a) |
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31.2**
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Certification of Chief Financial Officer pursuant to Rule 13a-14(a)/15d-14(a) |
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32.1**
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Certification of Chief Executive Officer pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 |
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32.2**
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Certification of Chief Financial Officer pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 |
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* |
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Previously filed with our Form 10-KSB on March 26, 2008 |
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** |
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Filed with this Form 10-KSB/A |
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Compensation Plan or Arrangement or Management Contract |
35
SIGNATURES
In accordance with Section 13 or 15(d) of the Exchange Act, the registrant caused this report
to be signed on its behalf by the undersigned, thereunto duly authorized.
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Date: April 24, 2008 |
SAFESTITCH MEDICAL, INC.
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By: |
/s/ Jeffrey G. Spragens
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Jeffrey G. Spragens |
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Chief Executive Officer and President |
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36
Ex-23.1 Consent of Eisner LLP
Exhibit 23.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation by reference in the Registration Statements on Form S-8
(Registration Nos. 333-0849 and 333-44410) of our report dated
March 26, 2008, except for Note O, as to which the date is
April 24, 2008, with respect to our
audits of the consolidated financial statements of SafeStitch Medical, Inc. (formerly known as
Cellular Technical Services Company, Inc.) as of December 31,
2007 and for the years ended December 31, 2007 and 2006 and for the period from September 15, 2005 (inception) through December 31, 2007, included in
the Annual Report in Form 10-KSB, as amended by Amendment No. 1 for the year ended December 31, 2007 filed with the Securities and
Exchange Commission.
/s/ Eisner LLP
New York, New York
April 24, 2008
Ex-31.1 Section 302 Certification of CEO
Exhibit 31.1
CERTIFICATIONS
I, Jeffrey G. Spragens, certify that:
1. |
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I have reviewed this Annual Report on Form 10-KSB/A of SafeStitch Medical, Inc.; |
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2. |
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Based on my knowledge, this report does not contain any untrue statement of a material fact
or omit to state a material fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading with respect to the period
covered by this report; |
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3. |
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Based on my knowledge, the financial statements, and other financial information included in
this report, fairly present in all material respects the financial condition, results of
operations and cash flows of the registrant as of, and for, the periods presented in this
report; |
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4. |
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The small business issuers other certifying officer(s) and I are responsible for
establishing and maintaining disclosure controls and procedures (as defined in Exchange Act
Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in
Exchange Act Rules 13a-15(f) and 15d-15(f)) for the small business issuer and have: |
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a. |
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Designed such disclosure controls and procedures, or caused such
disclosure controls and procedures to be designed under our supervision, to ensure
that material information relating to the small business issuer, including its
consolidated subsidiaries, is made known to us by others within those entities,
particularly during the period in which this report is being prepared; |
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b. |
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Designed such internal control over financial reporting, or caused such
internal control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial reporting and
the preparation of financial statements for external purposes in accordance with
generally accepted accounting principles; |
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c. |
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Evaluated the effectiveness of the small business issuers disclosure
controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the
period covered by this report based on such evaluation; and |
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d. |
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Disclosed in this report any change in the small business issuers
internal control over financial reporting that occurred during the small business
issuers most recent fiscal quarter (the small business issuers fourth fiscal
quarter in the case of an annual report) that has materially affected, or is
reasonably likely to materially affect, the registrants internal control over
financial reporting; and |
5. |
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The small business issuers other certifying officer(s) and I have disclosed, based on our
most recent evaluation of internal control over financial reporting, to the small business
issuers auditors and the audit committee of the small business issuers board of directors
(or persons performing the equivalent functions): |
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a. |
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All significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are reasonably likely
to adversely affect the small business issuers ability to record, process,
summarize and report financial information; and |
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b. |
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Any fraud, whether or not material, that involves management or other
employees who have a significant role in the small business issuers internal
control over financial reporting. |
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By: |
/s/ Jeffrey G. Spragens
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Jeffrey G. Spragens |
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Chief Executive
Officer (Principal Executive Officer)
April 24, 2008 |
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Ex-31.2 Section 302 Certification of CFO
Exhibit 31.2
CERTIFICATIONS
I, Adam S. Jackson, certify that:
1. |
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I have reviewed this Annual Report on Form 10-KSB/A of SafeStitch Medical, Inc.; |
2. |
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Based on my knowledge, this report does not contain any untrue statement of a material fact
or omit to state a material fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading with respect to the period
covered by this report; |
3. |
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Based on my knowledge, the financial statements, and other financial information included in
this report, fairly present in all material respects the financial condition, results of
operations and cash flows of the registrant as of, and for, the periods presented in this
report; |
4. |
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The small business issuers other certifying officer(s) and I are responsible for
establishing and maintaining disclosure controls and procedures (as defined in Exchange Act
Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in
Exchange Act Rules 13a-15(f) and 15d-15(f)) for the small business issuer and have: |
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a. |
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Designed such disclosure controls and procedures, or caused such
disclosure controls and procedures to be designed under our supervision, to ensure
that material information relating to the small business issuer, including its
consolidated subsidiaries, is made known to us by others within those entities,
particularly during the period in which this report is being prepared; |
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b. |
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Designed such internal control over financial reporting, or caused such
internal control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial reporting and
the preparation of financial statements for external purposes in accordance with
generally accepted accounting principles; |
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c. |
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Evaluated the effectiveness of the small business issuers disclosure
controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the
period covered by this report based on such evaluation; and |
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d. |
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Disclosed in this report any change in the small business issuers
internal control over financial reporting that occurred during the small business
issuers most recent fiscal quarter (the small business issuers fourth fiscal
quarter in the case of an annual report) that has materially affected, or is
reasonably likely to materially affect, the registrants internal control over
financial reporting; and |
5. |
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The small business issuers other certifying officer(s) and I have disclosed, based on our
most recent evaluation of internal control over financial reporting, to the small business
issuers auditors and the audit committee of the small business issuers board of directors
(or persons performing the equivalent functions): |
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a. |
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All significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are reasonably likely
to adversely affect the small business issuers ability to record, process,
summarize and report financial information; and |
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b. |
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Any fraud, whether or not material, that involves management or other
employees who have a significant role in the small business issuers internal
control over financial reporting. |
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By: |
/s/ Adam S. Jackson
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Adam S. Jackson |
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Chief Financial Officer
April 24, 2008 |
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Ex-32.1 Section 906 Certification of CEO
Exhibit 32.1
CERTIFICATION PURSUANT
TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the accompanying Annual Report on Form 10-KSB/A of SafeStitch Medical, Inc.
for the fiscal year ended December 31, 2007 (the Report), the undersigned hereby certifies
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002, to the best of my knowledge and belief, that:
(1) |
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the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities
Exchange Act of 1934; and |
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(2) |
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the information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of SafeStitch Medical, Inc. |
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By: |
/s/ Jeffrey G. Spragens
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Jeffrey G. Spragens |
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Chief Executive
Officer (Principal Executive Officer)
April 24, 2008 |
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The certification set forth above is being furnished as an Exhibit solely pursuant to Section
906 of the SarbanesOxley Act of 2002 and is not being filed as part of the Report or as a
separate disclosure document of SafeStitch Medical, Inc. or the certifying officers
Ex-32.2 Section 906 Certification of CFO
Exhibit 32.2
CERTIFICATION PURSUANT
TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the accompanying Annual Report on Form 10-KSB/A of SafeStitch Medical, Inc.
for the fiscal year ended December 31, 2007 (the Report), the undersigned hereby certifies
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002, to the best of my knowledge and belief, that:
(1) |
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the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities
Exchange Act of 1934; and |
(2) |
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the information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of SafeStitch Medical, Inc. |
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By: |
/s/ Adam S. Jackson
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Adam S. Jackson |
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Chief Financial Officer
April 24, 2008 |
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The certification set forth above is being furnished as an Exhibit solely pursuant to Section
906 of the SarbanesOxley Act of 2002 and is not being filed as part of the Report or as a
separate disclosure document of SafeStitch Medical, Inc. or the certifying officers