DMK PHARMACEUTICALS Corp - Quarter Report: 2008 September (Form 10-Q)
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
10-Q
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QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
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For
the quarterly period ended September 30, 2008
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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 _________
Commission
File Number: 0-26372
CELLEGY
PHARMACEUTICALS, INC.
(Exact
name of registrant as specified in its charter)
Delaware
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82-0429727
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(State
or other jurisdiction of
incorporation
or organization)
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(I.R.S.
Employer
Identification
Number)
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128
Grandview Road, Boyertown, PA 19512
(Address
of principal executive offices, including zip code)
215-529-6084
(Registrant’s
telephone number, including area code)
2085
Quaker Point Drive, Quakertown , Pa 18951
(Former
address of principal executive offices, including zip code)
Indicate
by check mark whether the registrant (1) has filed all reports required to
be
filed by Sections 13 or 15(d) of the Securities Exchange Act of 1934 during
the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements
for
the past 90 days. Yes x No o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company.
See
definitions of “larger accelerated filer”, “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act. (Check
one):
Large
accelerated filer ¨ Accelerated
filer ¨ Non-accelerated
filer ¨
Smaller
reporting company x
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes o No x
The
number of shares outstanding of the registrant’s common stock at September 30,
2008 was 29,834,796.
CELLEGY
PHARMACEUTICALS, INC.
CONTENTS
OF QUARTERLY REPORT ON FORM 10-Q
Page
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PART
I
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FINANCIAL
INFORMATION
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Item
1.
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Financial
Statements:
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Condensed
Consolidated Balance Sheets
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3
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Condensed
Consolidated Statements of Operations
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4
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Condensed
Consolidated Statements of Cash Flows
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5
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Notes
to Condensed Consolidated Financial Statements
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6
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Item
2.
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Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
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13
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Item
3.
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Quantitative
and Qualitative Disclosure of Market Risk
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17
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Item
4.
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Controls
and Procedures
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17
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PART
II
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OTHER
INFORMATION
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Item
1.
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Legal
Proceedings
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17
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Item
1A.
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Risk
Factors
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18
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Item
2.
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Unregistered
Sales of Equity Securities and Use of Proceeds
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18
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Item
3.
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Defaults
Upon Senior Securities
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18
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Item
4.
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Submission
of Matters to a Vote of Security Holders
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18
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Item
5.
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Other
Information
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18
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Item
6.
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Exhibits
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18
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Signatures
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19
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PART
I - FINANCIAL INFORMATION
Cellegy
Pharmaceuticals, Inc.
(Amounts
in thousands)
(Unaudited)
September
30, 2008
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December
31, 2007
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||||||
Assets
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|||||||
Current
assets:
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|||||||
Cash
and cash equivalents
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$
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361
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$
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1,827
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|||
Prepaid
expenses and other current assets
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43
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267
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|||||
Total
current assets
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404
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2,094
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|||||
Note
receivable
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500
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—
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|||||
Interest
receivable
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32
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—
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|||||
Total
assets
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$
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936
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$
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2,094
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|||
Liabilities
and Stockholders' Equity (Deficiency)
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|||||||
Current
liabilities:
|
|||||||
Accounts
payable
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$
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49
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$
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—
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|||
Accrued
expenses and other current liabilities
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175
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396
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|||||
Total
current liabilities
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224
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396
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|||||
Note
payable
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713
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507
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|||||
Derivative
instruments
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1
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1
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|||||
Total
liabilities
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938
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904
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|||||
Stockholders'
equity (deficiency):
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|||||||
Common
stock
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3
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3
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Additional
paid-in capital
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125,770
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125,753
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|||||
Accumulated
deficit
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(125,775
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)
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(124,566
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)
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Total
stockholders' equity (deficiency)
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(2
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)
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1,190
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Total
liabilities and stockholders' equity
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$
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936
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$
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2,094
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The
accompanying notes are an integral part of these condensed consolidated
financial statements.
3
Cellegy
Pharmaceuticals, Inc.
(Amounts
in thousands, except per share data)
(Unaudited)
Three
Months Ended
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Nine
Months Ended
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September
30,
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September
30,
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||||||||||||
2008
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2007
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2008
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2007
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||||||||||
Costs
and expenses:
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|||||||||||||
Research
and development
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$
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—
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$
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2
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$
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3
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$
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23
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|||||
Selling,
general and administrative
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262
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404
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1,060
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1,345
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|||||||||
Total
costs and expenses
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262
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406
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1,063
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1,368
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Operating
loss
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(262
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)
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(406
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)
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(1,063
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)
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(1,368
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)
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|||||
Other
income (expenses):
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|||||||||||||
Interest
and other income
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17
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147
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60
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203
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|||||||||
Interest
and other expense
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(76
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)
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(67
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)
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(206
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)
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(161
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)
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Derivative
revaluation
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—
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5
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—
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1
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Total
other income (expenses)
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(59
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)
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85
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(146
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)
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43
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Net
loss
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$
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(321
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)
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$
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(321
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)
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$
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(1,209
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)
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$
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(1,325
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)
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Earnings
per common share:
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Loss
per common share:
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$
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(0.01
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)
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$
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(0.01
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)
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$
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(0.04
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)
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$
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(0.04
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)
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Weighted
average number of common shares used in per share
calculations:
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29,835
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29,835
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29,835
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29,835
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The
accompanying notes are an integral part of these condensed consolidated
financial statements.
4
Cellegy
Pharmaceuticals, Inc.
(Amounts
in thousands)
(Unaudited)
Nine
Months Ended September 30,
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|||||||
2008
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2007
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||||||
Operating
activities
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|||||||
Net
loss
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$
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(1,209
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)
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$
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(1,325
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)
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Adjustments
to reconcile net loss from continuing operations
to net cash used in operating activites:
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Equity
compensation expense
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17
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40
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|||||
Derivative
revaluation
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—
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(2
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)
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Interest
accretion on notes payable
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206
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131
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|||||
Interest
on long term note receivable
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(32
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)
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—
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Forgiveness
of debt
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—
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(5
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)
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Changes
in operating assets and liabilitites:
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|||||||
Prepaid
expenses and other current assets
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224
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(15
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)
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||||
Accounts
receivable
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—
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77
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|||||
Accounts
payable
|
49
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(159
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)
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||||
Accrued
expenses and other current liabilities
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(221
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)
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(371
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)
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|||
Net
cash used in operating activities
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(966
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)
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(1,629
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)
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Investing
activity:
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|||||||
Issuance
of long term note receivable
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(500
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)
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—
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||||
Net
cash used in investing activity
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(500
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)
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—
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||||
Financing
activity:
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|||||||
Repayment
of note payable
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—
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(40
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)
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||||
Net
cash used in financing activity
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—
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(40
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)
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Net
decrease in cash and cash equivalents
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(1,466
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)
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(1,669
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)
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Cash
and cash equivalents, beginning of period
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1,827
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3,804
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Cash
and cash equivalents, end of period
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$
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361
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$
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2,135
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The
accompanying notes are an integral part of these condensed consolidated
financial statements.
5
Cellegy
Pharmaceuticals, Inc.
Notes
to Condensed Consolidated Financial Statements
(Unaudited)
Note
1: Basis of Presentation
The
accompanying unaudited interim condensed consolidated financial statements
have
been prepared in accordance with generally accepted accounting principles for
interim financial information and with the instructions to Form 10-Q and Article
10 of Regulation S-X promulgated by the Securities and Exchange
Commission. Accordingly, certain information and footnote disclosures
normally included in annual financial statements have been condensed or omitted.
In the opinion of management, the accompanying unaudited interim condensed
consolidated financial statements reflect all adjustments (including normal
recurring adjustments and the elimination of intercompany accounts) considered
necessary for a fair statement of all periods presented. The results of Cellegy
Pharmaceuticals, Inc. (“Cellegy” or “the Company”) operations for any interim
periods are not necessarily indicative of the results of operations for any
other interim period or for a full fiscal year. These unaudited interim
condensed consolidated financial statements should be read in conjunction with
the consolidated financial statements and footnotes thereto included in
Cellegy’s Annual Report on Form 10-K for the year ended December 31,
2007.
Liquidity
and Capital Resources
On
February 12, 2008, Cellegy entered into a definitive merger agreement (as
amended, the “Merger Agreement”) providing for the acquisition of Cellegy by
Adamis Pharmaceuticals Corporation (“Adamis”). Adamis is a privately held
specialty pharmaceuticals company that is engaged in the research, development
and commercialization of products for the prevention of viral infections,
including influenza. Adamis currently markets and sells a line of prescription
products for a variety of allergy, respiratory disease and pediatric conditions.
The transaction was unanimously approved by the boards of directors of both
companies. The closing of the transaction is subject to several closing
conditions, including the filing of a registration statement and proxy statement
with the Securities and Exchange Commission (“SEC”), the approval of Adamis’ and
Cellegy’s respective stockholders at stockholder meetings following distribution
of a definitive proxy statement, and other customary closing conditions. Holders
of approximately 40% of Cellegy’s outstanding common stock have entered into
voting agreements pursuant to which they agreed to vote their shares in favor
of
the transaction. The combined company expects to continue to be publicly traded
after completion of the merger, although under a different corporate name.
On
November 13, 2008, Cellegy filed a Form S-4 registration statement, which
includes a preliminary proxy statement, with the SEC relating to the merger
transaction with Adamis and certain related matters.
If
the
merger is consummated, each Adamis stockholder will receive, in exchange for
each share of Adamis common stock held by such stockholder immediately before
the closing, one (post-reverse stock split) share of Cellegy common stock
(excluding in all cases dissenting shares). If the transaction is approved
by
Cellegy’s stockholders, before the closing Cellegy will implement a reverse
stock split of its common stock so that the outstanding Cellegy shares will
be
converted into a number of shares equal to the sum of (i) 3,000,000 plus (ii)
the amount of Cellegy’s net working capital as of the end of the month
immediately preceding the month in which the closing occurs divided by .50.
Based on several assumptions that are subject to change, including, without
limitation, the number of shares of Cellegy common stock outstanding immediately
before the merger and the amount of Cellegy’s current assets and liabilities as
of the end of the month immediately prior to the closing, Cellegy estimates
that
the reverse stock split ratio will be approximately 1:9.9. The actual amounts
and percentages will depend on many factors, and actual amounts and percentage
could be higher or lower.
In
addition, the Merger Agreement contains certain termination rights for both
Cellegy and Adamis, and further provides that, upon termination of the merger
agreement under specified circumstances, either party may be required to pay
the
other party a termination fee of $150,000. Both parties have the right to
terminate the Merger Agreement if the merger is not consummated by December
31,
2008, so long as the terminating party is not in breach of the Merger Agreement
and such breach is a principal failure of the merger to occur by such date.
6
In
connection with the signing of the Merger Agreement, Cellegy also issued to
Adamis an unsecured convertible promissory note (the “Promissory Note”) pursuant
to which Cellegy agreed to lend Adamis $500,000 to provide additional funds
to
Adamis during the pendency of the merger transaction. Any principal outstanding
under the Promissory Note accrues interest at 10% per annum. The Promissory
Note
becomes immediately due and payable in the event that the Merger Agreement
is
terminated by Adamis or Cellegy for certain specified reasons or on the later
of
(i) the sixteen month anniversary of the issue date of the Promissory Note
or
(ii) the date that is two business days following the first date on which
certain other notes issued by Adamis to a third party have been repaid in full.
If the Promissory Note is outstanding as of the closing of the merger
transaction, the Promissory Note will not be repaid, but will convert into
shares of Adamis stock and these shares will be immediately cancelled. Cellegy
will receive no additional shares. The terms of the Promissory Note provide
Cellegy with no collateralized interest in the assets of Adamis. In the event
the merger is not consummated with Adamis, Cellegy bears the risk of collecting
the Promissory Note and therefore is subject to the risks and uncertainties
of
being in the position of an unsecured creditor. While the Company feels that
it
is more likely than not that the merger will be consummated, in the event it
is
not, the Cellegy will have no ability to attach a claim to Adamis’
assets.
There
is
no assurance that the Company will be able to close the transaction with Adamis.
If the proposed merger transaction with Adamis is still pending and Cellegy
requires additional cash resources to complete the transaction, Cellegy and
Adamis are engaged in discussions concerning an agreement for Adamis to provide
funding sufficient to permit the merger to be completed, although there can
be
no assurance that such funding will be available.
If
the
merger with Adamis is not completed, Cellegy’s board of directors will be
required to explore alternatives for Cellegy’s business and assets. These
alternatives might include seeking the dissolution and liquidation of Cellegy,
merging or combining with another company, or initiating bankruptcy proceedings.
There can be no assurance that any third party will be interested in merging
with Cellegy or acquiring the remaining assets of Cellegy. Although Cellegy
may
try to pursue an alternative strategic transaction, it will likely have very
limited cash resources, and will likely be forced to file for federal bankruptcy
protection. If Cellegy files for bankruptcy protection, Cellegy will most likely
not be able to raise any type of funding from any source. In that event, the
creditors of Cellegy would have first claim on the value of the assets of
Cellegy which, other than remaining cash, would most likely be liquidated in
a
bankruptcy sale. Cellegy can give no assurance as to the magnitude of the net
proceeds of such sale and whether such proceeds would be sufficient to satisfy
Cellegy’s obligations to its creditors, let alone to permit any distribution to
its equity holders. The condensed consolidated financial statements do not
include any adjustments that might result from the outcome of this uncertainty.
These factors raise substantial doubt about our ability to continue as a going
concern.
Note
2: Loss per Common Share
Loss
per
common share is computed using the weighted average number of common shares
outstanding during the period. Diluted net loss per common share incorporates
the incremental shares issued upon the assumed exercise of stock options and
warrants, when dilutive. There is no difference between basic and diluted net
loss per common share, as presented in the condensed consolidated statements
of
operations, because all options and warrants are anti-dilutive. The total number
of shares that had their impact excluded was (in thousands):
Three
and Nine Months Ended
|
|||||||
September
30,
|
|||||||
2008
|
2007
|
||||||
Options
|
1,333
|
1,363
|
|||||
Warrants
|
2,115
|
2,115
|
|||||
Total
number of shares excluded
|
3,448
|
3,478
|
7
Note
3: Stock-Based Compensation
In
the
condensed consolidated statement of operations for the third quarters of 2008
and 2007, the Company recorded stock based compensation expenses of $2,902
and
$16,154, respectively.
2005
Equity Incentive Plan (“2005 Plan”)
Options
Outstanding and Exercisable
|
||||||
Number
of Options
|
Weighted
Average Remaining Contractual Life
|
Weighted
Average Exercise Price
|
Aggregate
Intrinsic Value
|
|||
48,000
|
7.00
Years
|
$
1.34
|
$
—
|
There
were no grants, cancellations, or exercises of options under the 2005 Plan
during the quarter ended September 30, 2008 and 16,000 options vested in the
quarter ended September 30, 2008.
1995
Equity Incentive Plan (“Prior Plan”)
Options
Outstanding and Exercisable
|
||||||
Number
of Options
|
Weighted
Average Remaining Contractual Life
|
Weighted
Average Exercise Price
|
Aggregate
Intrinsic Value
|
|||
204,944
|
5.67
Years
|
$
2.66
|
$
—
|
There
were no grants, cancellations, exercises or vestings of options under
the Prior Plan during the quarter ended September 30, 2008. No future options
may be granted under the Prior Plan.
Directors’
Stock Option Plan (“Director’s Plan”)
Options
Outstanding and Exercisable
|
||||||
Number
of Options
|
Weighted
Average Remaining Contractual Life
|
Weighted
Average Exercise Price
|
Aggregate
Intrinsic Value
|
|||
84,000
|
4.50
Years
|
$
4.35
|
$
—
|
There
were no grants, cancellations, exercises or vestings of options during the
quarter ended September 30, 2008. No future options may be granted under the
Directors’ Plan.
Non-Plan
Options
In
November 2003, the Company granted an initial stock option to Mr. Richard C.
Williams, upon his appointment as Chairman of the Board, to purchase 1,000,000
shares of common stock. 400,000 and 600,000 options have exercise prices of
$2.89 and $5.00 per share, respectively. The options were vested and exercisable
in full on the grant date, although a portion of the option covering up to
600,000 shares initially and declining over time is subject to cancellation
if
they have not been exercised in the event that Mr. Williams voluntarily resigns
as Chairman and as director within certain future time periods. As of September
30, 2008 none of these options have been exercised and none are subject to
cancellation.
8
Biosyn
Options
In
October 2004, in conjunction with its acquisition of Biosyn, Cellegy issued
stock options to certain Biosyn option holders to purchase 236,635 shares of
Cellegy common stock. All options issued were immediately vested and
exercisable.
During
the quarter ended September 30, 2008, there were no grants, cancellations,
or
exercises under Biosyn options plan. The following table summarizes information
about stock options outstanding and exercisable related to Biosyn option grants
at September 30, 2008:
Options
Outstanding and Exercisable
|
||||||
Number
of Options
|
|
Weighted
Average Remaining Contractual Life
|
|
Weighted
Average Exercise Price
|
|
Aggregate
Intrinsic Value
|
4,283
|
|
5.31
Years
|
|
$
0.29
|
|
$
—
|
Shares
Reserved
As
of
September 30, 2008, the Company has reserved shares of common stock for issuance
upon exercise as follows:
Biosyn
options
|
4,283
|
|||
Director's
Plan
|
84,000
|
|||
Warrants
|
2,114,593
|
|||
Nonplan
options
|
1,000,000
|
|||
1995
Equity Incentive Plan
|
204,944
|
|||
2005
Equity Incentive Plan
|
1,000,000
|
|||
Total
|
4,407,820
|
Warrants
Warrant
Shares
|
Exercise
Price Per Share
|
Date
Issued
|
Expiration
Date
|
||||||||||
June
2004 PIPE
|
604,000
|
$
|
4.62
|
July
27, 2004
|
July
27, 2009
|
||||||||
Biosyn
warrants
|
81,869
|
5.84
- 17.52
|
October
22, 2004
|
2008
- 2014
|
|||||||||
May
2005 PIPE
|
|||||||||||||
Series
A
|
714,362
|
2.25
|
May
13, 2005
|
May
13, 2010
|
|||||||||
Series
B
|
714,362
|
2.50
|
May
13, 2005
|
May
13, 2010
|
|||||||||
Total
|
2,114,593
|
9
Note
4: Recent Accounting Pronouncements
SFAS No. 157,
Fair Value Measurements
In
September 2006, the Financial Accounting Standards Board (the “FASB”)
issued SFAS No. 157, “Fair
Value Measurements"(“SFAS
157”). SFAS 157 provides enhanced guidance for using fair value to measure
assets and liabilities and expands disclosure with respect to fair value
measurements. This statement was originally effective for fiscal years beginning
after November 15, 2007. In February 2008, the FASB issued FSP No.
157-2 which allows companies to elect a one year deferral of adoption of SFAS
157 for non-financial assets and non-financial liabilities that are recognized
or disclosed at fair value in the financial statements on a non-recurring basis.
On January 1, 2008, the Company adopted the provisions of SFAS 157 for
financial assets and liabilities. As permitted by FSP No.157-2, the Company
elected to defer the adoption of SFAS 157 for all non-financial assets and
non-financial liabilities, except those that are recognized or disclosed at
fair
value in the financial statements on a recurring basis, until January 1,
2009. SFAS 157 provides a framework for measuring fair value under U.S.
GAAP and requires expanded disclosures regarding fair value measurements.
SFAS 157 defines fair value as the exchange price that would be received
for an asset or paid to transfer a liability (an exit price) in the principal
or
most advantageous market for the asset or liability in an orderly transaction
between market participants on the measurement date. SFAS 157 also
establishes a fair value hierarchy which requires an entity to maximize the
use
of observable inputs, where available, and minimize the use of unobservable
inputs when measuring fair value. The standard describes three levels of inputs
that may be used to measure fair value:
Level
1
|
|
Quoted
prices in active markets for identical assets or liabilities. Our
Level 1
assets and liabilities include investments in marketable securities
and
cash equivalents.
|
|
|
|
|
|
Level
2
|
|
Observable
inputs other than Level 1 prices, such as quoted prices for similar
assets
or liabilities; quoted prices in markets that are not active; or
other
inputs that are observable or can be corroborated by observable market
data for substantially the full term of the assets or
liabilities.
|
|
|
|
|
|
Level
3
|
|
Unobservable
inputs that are supported by little or no market activity and that
are
significant to the fair value of the assets or
liabilities.
|
There
was
no impact upon the Company’s consolidated financial statements resulting from
the adoption of this pronouncement.
SFAS No. 141
(Revised 2007), Business Combinations
On
December 4, 2007, the FASB issued SFAS No. 141 (Revised 2007),
“Business
Combinations”
(“SFAS 141R”). Under SFAS 141R, an acquiring entity will be required
to recognize all the assets acquired and liabilities assumed in a transaction
at
the acquisition date fair value with limited exceptions. SFAS 141R will
change the accounting treatment for certain specific items including:
·
|
acquisition
costs will be generally expensed as
incurred;
|
·
|
non-controlling
interests will be valued at fair value at the acquisition
date;
|
·
|
acquired
contingent liabilities will be recorded at fair value at the acquisition
date and subsequently measured at either the higher of such amount
or the
amount determined under existing guidance for non-acquired
contingencies;
|
·
|
in-process
research and development will be recorded at fair value as an
indefinite-lived intangible asset at the acquisition date until the
completion or abandonment of the associated research and development
efforts;
|
·
|
restructuring
costs associated with a business combination will generally be expensed
subsequent to the acquisition
date; and
|
·
|
changes
in deferred tax asset valuation allowances and income tax uncertainties
after the acquisition date generally will affect income tax
expense.
|
10
SFAS 141R
also includes a substantial number of new disclosure requirements.
SFAS 141R applies prospectively to business combinations for which the
acquisition date is on or after the beginning of the first annual reporting
period beginning on or after December 15, 2008. Earlier adoption is
prohibited. The Company will adopt this statement in 2009.
SFAS No. 160,
“Non-controlling Interests in Consolidated Financial Statements — An
Amendment of ARB No. 51”
On
December 4, 2007, the FASB issued SFAS No. 160, “Non-controlling
Interests in Consolidated Financial Statements — An Amendment of ARB
No. 51”
(“SFAS 160”). SFAS 160 establishes new accounting and reporting
standards for the non-controlling interest in a subsidiary and for the
deconsolidation of a subsidiary. Specifically, this statement requires the
recognition of a non-controlling interest (minority interest) as equity in
the
consolidated financial statements and separate from the parent’s equity. The
amount of net income attributable to the non-controlling interest will be
included in consolidated net income on the face of the income statement.
SFAS 160 clarifies that changes in a parent’s ownership interest in a
subsidiary that do not result in deconsolidation are equity transactions if
the
parent retains its controlling financial interest. In addition, this statement
requires that a parent recognize a gain or loss in net income when a subsidiary
is deconsolidated. Such gain or loss will be measured using the fair value
of
the non-controlling equity investment on the deconsolidation date. SFAS 160
also includes expanded disclosure requirements regarding the interests of the
parent and its non-controlling interest. SFAS 160 is effective for fiscal
years, and interim periods within those fiscal years, beginning on or after
December 15, 2008. Earlier adoption is prohibited. The Company believes
that this pronouncement will have no effect on its financial
statements.
SFAS
No. 162, “The Hierarchy of Generally
Accepted Accounting Principles”
In
May 2008, the FASB issued SFAS No. 162, “The
Hierarchy of Generally Accepted Accounting Principles”
(“SFAS 162”),
which
identifies the sources of accounting principles and the framework for selecting
the principles to be used in the preparation of financial statements of
non-governmental entities that are presented in conformity with generally
accepted accounting principles (“GAAP”) in the United States. The effective date
of SFAS 162 is yet to be determined; it will become effective 60 days
following the SEC’s approval of the Public Company Accounting Oversight Board
amendments to AU Section 411, The
Meaning of Present Fairly in Conformity With Generally Accepted Accounting
Principles.
SFAS
162 is not expected to have a significant impact on the Company’s consolidated
financial statements.
Note
5: Prepaid
Expenses and Other Current Assets
Prepaid
expenses and other current assets consist of the following (in
thousands):
September
30,
|
December
31,
|
||||||
2008
|
2007
|
||||||
Prepaid
insurance
|
$
|
43
|
$
|
134
|
|||
Security
deposits
|
—
|
8
|
|||||
Retention
compensation
|
—
|
120
|
|||||
Other
|
—
|
5
|
|||||
$
|
43
|
$
|
267
|
11
Note 6: Accrued Expenses and Other Current Liabilities
The
Company accrues for goods and services received but for which billings have
not
been received. Accrued expenses and other current liabilities consist of the
following (in thousands):
September
30,
|
December
31,
|
||||||
2008
|
2007
|
||||||
Accrued
legal fees
|
$
|
18
|
$
|
29
|
|||
Accrued
compensation
|
71
|
30
|
|||||
Accrued
retention
|
—
|
139
|
|||||
Accrued
accounting and consulting fees
|
33
|
125
|
|||||
Insurance
payable
|
11
|
13
|
|||||
Other
|
42
|
60
|
|||||
Total
|
$
|
175
|
$
|
396
|
Accrued
retention represents the unamortized portion of approximately $139,000 in
retention payments offered and accepted by employees in 2007. The retention
payments were to be paid if the employee maintained his or her employment with
the Company through the retention period indicated in the individual’s retention
agreement. The retention payment was in lieu of all other severance or similar
payments that the Company may have been obligated to make under any other
existing agreement, arrangement or understanding, but would be in addition
to
any accrued salary and vacation earned through the end of the respective
retention period. As of September 30 2008, the retention periods were satisfied
and all retention payments have been made.
Note
7: Note Payable
Ben
Franklin Note
Biosyn
issued a note to Ben Franklin Technology Center of Southeastern Pennsylvania
(“Ben Franklin Note”) in October 1992, in connection with funding the
development of a compound to prevent the transmission of Acquired
Immunodeficiency Disease (“AIDS”).
The
Ben
Franklin Note was recorded at its estimated fair value of $205,000 and was
assumed by Cellegy in connection with its acquisition of Biosyn in 2004. The
repayment terms of the non-interest bearing obligation include the remittance
of
an annual fixed percentage of 3% applied to future revenues of Biosyn, if any,
until the principal balance of $777,902 is satisfied. Under the terms of the
obligation, revenues are defined to exclude the value of unrestricted research
and development funding received by Biosyn from nonprofit sources. There is
no
obligation to repay the amounts in the absence of future Biosyn revenues. The
Company is accreting the discount of $572,902 using the interest rate method
over the discount period of five years, which was estimated in connection with
the note’s valuation at the time of the acquisition. At September 30, 2008, the
outstanding balance of the note is $712,600.
Note
8: Derivative Instrument
The
warrants issued in connection with the May 2005 PIPE financing are revalued
at
the end of each reporting period as long as they remain outstanding. The
estimated fair value of all warrants, using the Black-Scholes valuation model,
recorded as derivative instruments liability at September 30, 2008 and December
31, 2007 was approximately $1,200. Any change in the estimated fair value of
the
warrants has been recorded as other income and expense in the condensed
consolidated statement of operations. For the three and nine months ended
September 30, 2008, the Company recognized no income or expense related to
derivative revaluation. For the three and nine months ended September 30, 2007,
the Company recognized expense of approximately $5,000 and income of
approximately $1,000, respectively, from derivative revaluation.
Note
9: Note Receivable
In
connection with the signing of the Merger Agreement with Adamis, Cellegy issued
to Adamis an unsecured convertible promissory note in the amount of $500,000
to
provide additional funds to Adamis during the pendency of the merger
transaction. Principal outstanding under the Promissory Note accrues interest
at
10% per annum. The Promissory Note becomes immediately due and payable in the
event that the Merger Agreement is terminated by Adamis or Cellegy for certain
specified reasons or on the later of (i) the sixteen month anniversary of the
issue date of the Promissory Note or (ii) the date that is two business days
following the first date on which certain other notes issued by Adamis to a
third party have been repaid in full. If the Promissory Note is outstanding
as
of the closing of the merger transaction, the Promissory Note will not be
repaid, but will convert into shares of Adamis stock, and these shares will
be
immediately cancelled. Cellegy will receive no additional shares. Due to the
uncertainty surrounding the timing of closing the merger transaction with
Adamis, if the transaction closes at all, the Company has shown the Promissory
Note and its related interest income accrual as long term.
12
The
following discussion of our financial condition and results of operations should
be read in conjunction with the financial statements and notes to those
statements included elsewhere in this Quarterly Report on Form 10-Q and our
most recent audited financial statements included in our Annual Report on
Form 10-K previously filed with the SEC. This discussion may contain
forward-looking statements that involve substantial risks and uncertainties.
These forward-looking statements are not historical facts, but are based on
current expectations, estimates and projections about our industry, our beliefs
and our assumptions. Words such as “believes,” “anticipates,” “expects,”
“intends” and similar expressions are intended to identify forward-looking
statements, but are not the exclusive means of identifying such statements.
These forward-looking statements are not guarantees of future performance and
concern matters that could subsequently differ materially from those described
in the forward-looking statements. Actual events or results may also differ
materially from those discussed in this Quarterly Report on Form 10-Q.
These risks and uncertainties include those described in “Management’s
Discussion and Analysis of Financial Condition and Results of Operations -
Factors That May Affect Future Operating Results” and elsewhere in this
Quarterly Report on Form 10-Q. Except as required by law, we undertake no
obligation to revise any forward-looking statements in order to reflect events
or circumstances that may arise after the date of this Quarterly Report on
Form 10-Q.
General
Cellegy
Pharmaceuticals is a specialty biopharmaceutical company. Cellegy has
intellectual property relating to a portfolio of proprietary product candidates
known as microbicides. The product candidates, which include both contraceptive
and non-contraceptive microbicides, are used intravaginally. Cellegy’s product
candidates include Savvy, which was the subject of Phase 3 clinical trials
in
Ghana and Nigeria for reduction in the transmission of Human Immunodeficiency
Virus (HIV)/Acquired Immunodeficiency Disease (IAIDS), both of which were
suspended in 2005 and 2006 and terminated before completion, and which is
currently in a Phase 3 contraception trial in the United States.
The
Company’s operations currently relate primarily to the ownership of its
intellectual property rights relating to the Savvy product candidate. Cellegy’s
intellectual property consists primarily of commercialization and territorial
marketing rights for its Savvy compounds as well as related patents, trademarks,
license agreements, manufacturing and formulation technologies, past research,
and out-license arrangements with certain philanthropic and governmental
organizations. Cellegy also monitors the progress of the Savvy Phase 3
contraceptive trial in the United States and provides regulatory support
for
both the current contraception trial and the suspended HIV trials.
Results
of Operations
Revenues.
The
Company had no revenues for the three and nine month periods ended September
30,
2008 and 2007 and does not expect to recognize revenue in the foreseeable
future.
Biosyn
benefits indirectly from agency funding paid to third party contractors in
support of its ongoing Phase 3 clinical trials. These payments from the funding
agencies are made directly to the service providers, not to Biosyn. Under the
terms of certain of its funding agreements, Biosyn has been granted the right
to
commercialize products supported by the funding in developed and developing
countries, and is obligated to make its commercialized products, if any,
available in developing countries, as well as to public sector agencies in
developed countries at prices reasonably above cost or at a reasonable royalty
rate.
Research
and Development Expenses.
Cellegy incurred no research and development expenses in the three month period
ended September 30, 2008. For the nine month period ending September 30, 2008,
the Company incurred research and development expenses of approximately $3,000.
In
the
three and nine month periods ending September 30, 2007, the Company incurred
research and development expenses of approximately $2,000 and $23,000,
respectively. The Company does not expect to incur significant research and
development expenses in 2008.
Selling,
General and Administrative Expenses.
Selling, general and administrative expenses for the three and nine month
periods ending September 30, 2008 were approximately $262,000 and $1,060,000,
respectively. Selling, general and administrative expenses for the three and
nine month periods ending September 30, 2007 were approximately $404,000 and
$1,345,000. Selling, general and administrative expenses consist primarily
of
legal fees, accounting and audit fees, regulatory expenses and salaries. The
reduction in 2008 expense levels compared to the comparable periods in 2007
is
primarily a result of reduced levels of operations.
13
Other
Income (Expenses).
Interest and other income for the three and nine month periods ending September
30, 2008 was approximately $17,000 and $60,000, respectively, as compared to
approximately $147,000 and $203,000 for the comparable periods in 2007. Interest
and other income consists primarily of interest income earned in connection
with
bank deposits and the note receivable with Adamis. The decrease in interest
income was primarily due to the decline in the Company’s cash deposits.
Interest
and other expense for the three and nine month periods ending September 30,
2008
was approximately $76,000 and $206,000, respectively, as compared to
approximately $67,000 and $161,000 for the comparable periods in 2007. The
increase in interest and other expense in the current period is due primarily
to
the increased interest accretion of the note payable to Ben
Franklin.
Liquidity
and Capital Resources
Our
cash
and cash equivalents were approximately $361,000 and $1,827,000 at September
30,
2008 and December 31, 2007, respectively. Cash and cash equivalents
decreased approximately $1,466,000 during the nine month period ending September
30, 2008 due to our $500,000 loan to Adamis in connection with the proposed
merger, related merger expenses and operating expenses incurred in connection
with Cellegy’s present level of operations.
We
prepared the condensed consolidated financial statements assuming that we will
continue as a going concern, which contemplates the realization of assets and
the satisfaction of liabilities during the normal course of business. In
preparing these condensed consolidated financial statements, consideration
was
given to Cellegy’s future business alternatives as described below, which may
preclude Cellegy from realizing the value of certain assets during their future
course of business.
Cellegy’s
operations currently relate primarily to the management of intellectual property
rights of its Biosyn subsidiary and the administration of the clinical and
regulatory affairs of its Savvy Phase 3 contraception trial. While the Savvy
Phase 3 contraception trial in the United States is ongoing, Cellegy is not
directly involved with the conduct and funding thereof, and it is uncertain
whether Savvy will be commercialized or whether Cellegy will ever realize
revenues there from. We therefore expect negative cash flows to continue for
the
foreseeable future. Cellegy believes that it presently has enough financial
resources to continue operations as they currently exist until approximately
the
end of 2008, absent unforeseen significant additional expenses. If the proposed
merger transaction with Adamis is still pending and Cellegy requires additional
cash resources to complete the transaction, Cellegy and Adamis are engaged in
discussions concerning an agreement for Adamis to provide funding sufficient
to
permit the merger to be completed, although there can be no assurance that
such
funding will be available.
On
February 12, 2008, Cellegy entered into a definitive merger agreement providing
for the acquisition of Cellegy by Adamis. In connection with the signing of
the
Merger Agreement, Cellegy issued to Adamis an unsecured convertible promissory
note pursuant to which Cellegy agreed to lend Adamis $500,000 to provide
additional funds to Adamis during the pendency of the merger transaction. Any
principal outstanding under the Promissory Note accrues interest at 10% per
annum. The Promissory Note becomes immediately due and payable in the event
that
the Merger Agreement is terminated by Adamis or Cellegy for certain specified
reasons or on the later of (i) the sixteen month anniversary of the issue date
of the Promissory Note or (ii) the date that is two business days following
the
first date on which certain other notes issued by Adamis to a third party have
been repaid in full. If the Promissory Note is outstanding as of the closing
of
the merger transaction, the Promissory Note will not be repaid but will convert
into shares of Adamis stock, and these shares will be immediately cancelled.
Cellegy will receive no additional shares. There is no assurance that Cellegy
will be able to close the transaction with Adamis.
If
the
merger with Adamis is not completed, Cellegy’s board of directors will be
required to explore alternatives for Cellegy’s business and assets. These
alternatives might include seeking the dissolution and liquidation of Cellegy,
merging or combining with another company, or initiating bankruptcy proceedings.
There can be no assurance that any third party will be interested in merging
with Cellegy or acquiring the remaining assets of Cellegy. Although Cellegy
may
try to pursue an alternative strategic transaction, it will likely have very
limited cash resources, and will likely be forced to file for federal bankruptcy
protection. If Cellegy files for bankruptcy protection, Cellegy will most likely
not be able to raise any type of funding from any source. In that event, the
creditors of Cellegy would have first claim on the value of the assets of
Cellegy which, other than remaining cash, would most likely be liquidated in
a
bankruptcy sale. Cellegy can give no assurance as to the magnitude of the net
proceeds of such sale and whether such proceeds would be sufficient to satisfy
Cellegy’s obligations to its creditors, let alone to permit any distribution to
its equity holders. The condensed consolidated financial statements do not
include any adjustments that might result from the outcome of this uncertainty.
These factors raise substantial doubt about our ability to continue as a going
concern.
14
The
condensed consolidated financial statements do not include any adjustments
that
might result from the outcome of this uncertainty. Any failure to dispel any
continuing doubts about our ability to continue as a going concern could
adversely affect our ability to enter into business combination or other
agreements, therefore making it more difficult to obtain required financing
on
favorable terms or at all. Such an outcome may negatively affect the market
price of our common stock and could otherwise have a material adverse effect
on
our business, financial condition and results of operations.
On
November 13, 2008, Cellegy filed a Form S-4 registration statement, which
includes a preliminary proxy statement, with the SEC relating to the proposed
merger transaction with Adamis and related matters and the registration
statement includes additional information about the proposed merger.
Recent
Accounting Pronouncements
SFAS No. 157,
Fair Value Measurements
In
September 2006, the Financial Accounting Standards Board (the “FASB”)
issued SFAS No. 157, “Fair
Value Measurements"(“SFAS
157”). SFAS 157 provides enhanced guidance for using fair value to measure
assets and liabilities and expands disclosure with respect to fair value
measurements. This statement was originally effective for fiscal years beginning
after November 15, 2007. In February 2008, the FASB issued FSP No.
157-2 which allows companies to elect a one year deferral of adoption of SFAS
157 for non-financial assets and non-financial liabilities that are recognized
or disclosed at fair value in the financial statements on a non-recurring basis.
On January 1, 2008, the Company adopted the provisions of SFAS 157 for
financial assets and liabilities. As permitted by FSP No.157-2, the Company
elected to defer the adoption of SFAS 157 for all non-financial assets and
non-financial liabilities, except those that are recognized or disclosed at
fair
value in the financial statements on a recurring basis, until January 1,
2009. SFAS 157 provides a framework for measuring fair value under U.S.
GAAP and requires expanded disclosures regarding fair value measurements.
SFAS 157 defines fair value as the exchange price that would be received
for an asset or paid to transfer a liability (an exit price) in the principal
or
most advantageous market for the asset or liability in an orderly transaction
between market participants on the measurement date. SFAS 157 also
establishes a fair value hierarchy which requires an entity to maximize the
use
of observable inputs, where available, and minimize the use of unobservable
inputs when measuring fair value. The standard describes three levels of inputs
that may be used to measure fair value:
Level
1
|
|
Quoted
prices in active markets for identical assets or liabilities. Our
Level 1
assets and liabilities include investments in marketable securities
and
cash equivalents.
|
|
|
|
|
|
Level
2
|
|
Observable
inputs other than Level 1 prices, such as quoted prices for similar
assets
or liabilities; quoted prices in markets that are not active; or
other
inputs that are observable or can be corroborated by observable market
data for substantially the full term of the assets or
liabilities.
|
|
|
|
|
|
Level
3
|
|
Unobservable
inputs that are supported by little or no market activity and that
are
significant to the fair value of the assets or
liabilities.
|
There
was
no impact upon the Company’s consolidated financial statements resulting from
the adoption of this pronouncement.
15
SFAS No. 141
(Revised 2007), Business Combinations
On
December 4, 2007, the FASB issued SFAS No. 141 (Revised 2007),
“Business
Combinations”
(“SFAS 141R”). Under SFAS 141R, an acquiring entity will be required
to recognize all the assets acquired and liabilities assumed in a transaction
at
the acquisition date fair value with limited exceptions. SFAS 141R will
change the accounting treatment for certain specific items
including:
·
|
acquisition
costs will be generally expensed as
incurred;
|
·
|
non-controlling
interests will be valued at fair value at the acquisition
date;
|
·
|
acquired
contingent liabilities will be recorded at fair value at the acquisition
date and subsequently measured at either the higher of such amount
or the
amount determined under existing guidance for non-acquired
contingencies;
|
·
|
in-process
research and development will be recorded at fair value as an
indefinite-lived intangible asset at the acquisition date until the
completion or abandonment of the associated research and development
efforts;
|
·
|
restructuring
costs associated with a business combination will generally be expensed
subsequent to the acquisition
date; and
|
·
|
changes
in deferred tax asset valuation allowances and income tax uncertainties
after the acquisition date generally will affect income tax
expense.
|
SFAS 141R
also includes a substantial number of new disclosure requirements.
SFAS 141R applies prospectively to business combinations for which the
acquisition date is on or after the beginning of the first annual reporting
period beginning on or after December 15, 2008. Earlier adoption is
prohibited. The Company will adopt this statement in 2009.
SFAS No. 160,
“Non-controlling Interests in Consolidated Financial Statements — An
Amendment of ARB No. 51”
On
December 4, 2007, the FASB issued SFAS No. 160, “Non-controlling
Interests in Consolidated Financial Statements — An Amendment of ARB
No. 51”
(“SFAS 160”). SFAS 160 establishes new accounting and reporting
standards for the non-controlling interest in a subsidiary and for the
deconsolidation of a subsidiary. Specifically, this statement requires the
recognition of a non-controlling interest (minority interest) as equity in
the
consolidated financial statements and separate from the parent’s equity. The
amount of net income attributable to the non-controlling interest will be
included in consolidated net income on the face of the income statement.
SFAS 160 clarifies that changes in a parent’s ownership interest in a
subsidiary that do not result in deconsolidation are equity transactions if
the
parent retains its controlling financial interest. In addition, this statement
requires that a parent recognize a gain or loss in net income when a subsidiary
is deconsolidated. Such gain or loss will be measured using the fair value
of
the non-controlling equity investment on the deconsolidation date. SFAS 160
also includes expanded disclosure requirements regarding the interests of the
parent and its non-controlling interest. SFAS 160 is effective for fiscal
years, and interim periods within those fiscal years, beginning on or after
December 15, 2008. Earlier adoption is prohibited. The Company believes
that this pronouncement will have no effect on its financial
statements.
SFAS
No. 162, “The Hierarchy of Generally
Accepted Accounting Principles”
In
May 2008, the FASB issued SFAS No. 162, “The
Hierarchy of Generally Accepted Accounting Principles” (“SFAS 162”),
which
identifies the sources of accounting principles and the framework for selecting
the principles to be used in the preparation of financial statements of
non-governmental entities that are presented in conformity with generally
accepted accounting principles (“GAAP”) in the United States. The effective date
of SFAS 162 is yet to be determined; it will become effective 60 days
following the SEC’s approval of the Public Company Accounting Oversight Board
amendments to AU Section 411, The
Meaning of Present Fairly in Conformity With Generally Accepted Accounting
Principles.
SFAS
162 is not expected to have a significant impact on the Company’s consolidated
financial statements.
16
Critical
Accounting Policies and Estimates
Our
critical accounting policies and estimates were discussed in our Annual Report
on Form 10-K for the year ended December 31, 2007. No changes in those
policies and estimates have occurred during the nine months ended September
30,
2008.
ITEM
3. Quantitative and Qualitative Disclosure of Market Risk
Cellegy
invests its excess cash in short-term, investment grade, fixed income securities
under an investment policy. All of our securities owned as of September 30,
2008, were in money market funds and are classified as cash equivalents. We
believe that potential near-term losses in future earnings, fair values or
cash
flows related to our investment portfolio are not significant. We currently
do
not hedge interest rate exposure. If market interest rates were to increase
or
decrease, the fair value of our portfolio would not be significantly
affected.
We
are
incurring market risk associated with the issuance of warrants to the May 2005
PIPE investors to purchase approximately 1.4 million shares of our common stock.
We will continue to calculate the fair value at the end of each quarter and
record the difference to other income or expense until the warrants are
exercised or expired. We are incurring risk associated with increases or
decreases in the market price of our common stock, which will directly impact
the fair value calculation and the non-cash charge or credit recorded to the
statement of operations in future quarters.
ITEM
4. Controls and Procedures
As
of the
end of the period covered by this report, we carried out an evaluation, under
the supervision and with the participation of our management, including our
Chief Executive Officer and Chief Financial Officer, of the effectiveness of
the
design and operation of our disclosure controls and procedures (as defined
in
Exchange Act Rules 13a-15(e) and 15d-15(e)).
Based
upon this evaluation, our Chief Executive Officer and our Chief Financial
Officer concluded that, as of the end of the period covered by this report,
our
disclosure controls and procedures were effective to ensure that information
required to be disclosed in the reports filed or submitted under the Exchange
Act is recorded, processed, summarized and reported within the time periods
specified in the United States Securities and Exchange Commission rules and
forms.
During
the period covered by this report, there have been no changes in our internal
control over financial reporting that have materially affected, or are
reasonably likely to materially affect, our internal control over financial
reporting. A controls system, no matter how well designed and operated,
cannot provide absolute assurance that the objectives of the controls are met,
and no evaluation of controls can provide absolute assurance that all controls
and instances of fraud, if any, within a company have been
detected.
PART
II - OTHER INFORMATION
None
17
ITEM
1A. Risk Factors
As
a
smaller reporting company, Cellegy is not required under the rules of the
Securities and Exchange Commission, or SEC, to provide information under this
Item. Risks and uncertainties relating to the amount of Cellegy’s cash and cash
equivalents at September 30, 2008, the period of time that Cellegy believes
its
cash will be sufficient to conduct operations, risks and uncertainties relating
to the proposed Adamis merger transaction, and risks and uncertainties if the
merger transaction with Adamis is not completed, are discussed above under
the
heading, “Liquidity and Capital Resources” in the Management’s Discussion and
Analysis of Financial Condition and Results of Operations” section of this Form
10-Q, and are incorporated herein by this reference. Other material risks and
uncertainties associated with Cellegy’s business have been previously disclosed
in our most recent annual report on Form 10-K for the year ended December 31,
2007, including under the heading “Risk Factors,” as modified by subsequent
disclosures in our quarterly reports on Form 10-Q and other documents filed
with
the SEC. In addition, on November 13, 2008, Cellegy filed a registration
statement on Form S-4, which includes a preliminary proxy statement, with the
SEC relating to the proposed reverse stock split and subsequent issuance of
Cellegy shares pursuant to the proposed merger transaction with Adamis and
certain related matters. The registration statement, under the heading “Risk
Factors,” identifies various risks and uncertainties relating to the proposed
merger transaction, Cellegy, Adamis, and the combined company if the merger
is
completed, and as those disclosures have been previously reported in a filing
with the SEC, they are not repeated in this Item but are incorporated herein
by
reference.
None
None
None
ITEM
5. Other Information
None
a)
Exhibits
2.1
|
Agreement
dated November 11, 2008, between Cellegy and Adamis Pharmaceuticals
Corporation amending the Agreement and Plan of Reorganization
dated
February 12, 2008. (Incorporated by reference to Exhibit 2.1
to the Report
on Form 8-K filed with the SEC by Cellegy on November 12,
2008.)
|
|
31.1
|
Certification
of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
|
|
|
|
|
31.2
|
Certification
of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
|
|
|
|
|
32.1
|
Certification
of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002
|
|
|
|
|
32.2
|
Certification
of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002
|
|
99.1
|
Risk
Factors incorporated by reference from the Form S-4 registration
statement
filed by the Registrant with the SEC on November 13,
2008.
|
18
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
CELLEGY
PHARMACEUTICALS, INC.
|
||
|
|
|
Date: November 14, 2008 | /s/ Richard C. Williams | |
Richard C. Williams |
||
Chairman
and Interim Chief Executive Officer
|
|
|
|
Date: November 14, 2008 | /s/ Robert J. Caso | |
Robert J. Caso |
||
Vice
President, Finance and Chief Financial
Officer
|
19