HARROW, INC. - Quarter Report: 2008 June (Form 10-Q)
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
(Mark
One)
x
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QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE OF
1934
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For
the
quarterly period ended June
30, 2008
o
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TRANSITION
REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE
ACT
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Commission
file number: 000-52998
Transdel
Pharmaceuticals, Inc.
(Exact
Name of Registrant in Its Charter)
Delaware
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45-0567010
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(State
or Other Jurisdiction of Incorporation
or
Organization)
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(I.R.S.
Employer Identification No.)
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4225
Executive Square, Suite 485
La
Jolla, CA
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92037
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(Address
of Principal Executive Offices)
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(Zip
Code)
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(858)
457-5300
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(Registrant’s
Telephone Number, Including Area Code)
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4225
Executive Square, Suite 460
La
Jolla, CA 92037
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(Former
Name, Former Address and Former Fiscal Year, if Changed Since Last
Report)
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Indicate
by check mark whether the registrant: (1) has filed all reports required to
be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements
for
the past 90 days. Yes x
No
o
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). YES ¨ NO
x
As
of
August 7, 2008, 15,545,184 shares of issuer’s common stock, with $0.001 par
value per share were outstanding.
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company.
See
the definitions of “large accelerated filer”, “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act (Check
One):
Large
accelerated filer o
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Accelerated
filer o
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Non-accelerated
filer o
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Smaller
reporting company x
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(Do
not check if a smaller reporting company)
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(A
Development Stage Company)
Table
of Contents
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Page
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Part
I
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FINANCIAL
INFORMATION
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2
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Item
1.
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Financial
Statements
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2
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Condensed
Consolidated Balance Sheets - June 30, 2008 (Unaudited) and December
31, 2007
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2
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Unaudited
Condensed Consolidated Statements of Operations for the three and
six-month periods ended June 30, 2008 and 2007
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3
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Unaudited
Condensed Consolidated Statements of Cash Flows for the six-month
periods
ended June 30, 2008 and 2007
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4
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Notes
to the Unaudited Condensed Consolidated Financial
Statements
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5
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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
4T.
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Controls
and Procedures
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15
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Part
II
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OTHER
INFORMATION
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16
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Item
2.
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Unregistered
Sales of Equity Securities and Use of Proceeds
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16
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Item
6.
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Exhibits
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16
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i
FINANCIAL
INFORMATION
Item
1. Financial
Statements.
TRANSDEL
PHARMACEUTICALS, INC.
(A
Development Stage Company)
CONDENSED
CONSOLIDATED BALANCE SHEETS
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June
30, 2008 |
December
31, 2007 |
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(Unaudited)
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ASSETS
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|
|||||
Current
assets:
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|
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Cash
and cash equivalents
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$
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6,710,629
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$
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3,706,369
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Prepaid
consulting fees
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138,751
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488,748
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Prepaid
expenses and other current assets
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330,067
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45,604
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Total
current assets
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7,179,447
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4,240,721
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Equipment,
net
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2,978
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—
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|||||
Total
assets
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$
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7,182,425
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$
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4,240,721
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LIABILITIES
AND STOCKHOLDERS’ EQUITY
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Current
liabilities:
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Accounts
payable
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$
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879,416
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$
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696,340
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|||
Accrued
expenses and payroll liabilities
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41,363
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53,901
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Total
liabilities
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920,779
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750,241
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Stockholders’
equity:
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|||||||
Preferred
stock, $0.001 par value; 5,000,000 shares authorized, none
outstanding
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—
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—
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|||||
Common
stock, $0.001 par value; 50,000,000 shares authorized, 15,545,184
and
13,727,004 shares outstanding as of June 30, 2008 and December 31,
2007,
respectively
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15,545
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13,727
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Additional
paid-in capital
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14,859,680
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10,554,298
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Deficit
accumulated during the development stage
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(8,613,579
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)
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(7,077,545
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)
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Total
stockholders’ equity
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6,261,646
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3,490,480
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Total
liabilities and stockholders’ equity
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$
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7,182,425
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$
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4,240,721
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2
(A
Development Stage Company)
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Three
Months Ended June 30,
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Six
Months Ended June 30,
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For
the Period From July 24, 1998 (Inception) Through June
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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2008
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Operating
expenses:
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Selling,
general and administrative
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$
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562,324
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$
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151,115
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$
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1,010,179
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$
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251,336
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$
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4,093,760
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Research
and development
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718,083
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47,547
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937,183
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85,047
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3,494,927
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Operating
loss
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1,280,407
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198,662
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1,947,362
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336,383
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7,588,687
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Other
income (expense):
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Interest
expense
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—
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(8,394
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)
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—
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(10,601
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)
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(1,575,755
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)
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Interest
income
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17,094
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1,369
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36,328
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1,369
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85,949
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Gain
on forgiveness of liabilities
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—
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89,914
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—
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89,914
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89,914
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Gain
on settlement
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—
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—
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375,000
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—
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375,000
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Total
other income (expense), net
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17,094
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82,889
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411,328
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80,682
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(1,024,892
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)
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Net
loss
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$
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(1,263,313
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)
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$
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(115,773
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)
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$
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(1,536,034
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)
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$
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(255,701
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)
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$
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8,613,579
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Basic
and diluted loss per common share
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$
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(0.09
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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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(0.11
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)
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$
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(0.04
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)
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Weighted
average common shares outstanding
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14,726,004
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7,793,441
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14,226,504
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6,421,544
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(A
Development Stage Company)
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
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Six Months Ended June
30, |
For The Period From July 24,(Inception) Through |
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2008
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2007
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2008
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Cash
from operating activities:
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Net
loss
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$
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(1,536,034
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)
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$
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(255,701
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)
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$
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(8,613,579
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)
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Adjustments
to reconcile net loss to net cash used in
operating activities:
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Estimated
fair value of contributed services
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—
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175,000
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2,475,000
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Gain
on forgiveness of liabilities
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—
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—
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(89,914
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)
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Amortization
of prepaid consulting fees and depreciation
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303,983
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—
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505,235
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Non-cash
interest on notes payable
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—
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10,601
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1,575,755
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Stock-based
compensation
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412,089
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—
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596,611
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Changes
in operating assets and liabilities:
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Prepaid
consulting costs
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—
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—
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(140,000
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)
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Prepaid
expenses and other current assets
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(284,463
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)
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(96,802
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)
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(330,067
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)
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Accounts
payable
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183,076
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(96,260
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)
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969,330
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Accrued
expenses and payroll liabilities
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(12,538
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)
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32,177
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41,363
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Net
cash used in operating activities
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(933,887
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)
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(230,985
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)
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(3,010,266
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)
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Cash
flows from investing activities:
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||||||||||
Purchase
of equipment
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(3,154
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)
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—
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(3,154
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)
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|||||
Net
cash used in investing activities
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(3,154
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)
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—
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(3,154
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)
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Cash
flows from financing activities:
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Proceeds
from notes payable to stockholders
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—
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—
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226,300
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|||||||
Proceeds
from notes payable
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—
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1,500,000
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1,500,000
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|||||||
Capital
contributions
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—
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105,907
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168,707
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|||||||
Proceeds
from purchase of common stock and exercise of warrants and stock
options
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—
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25,700
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49,950
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|||||||
Net
proceeds from Private Placements
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3,941,301
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—
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7,779,092
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|||||||
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Net
cash provided by financing activities
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3,941,301
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1,631,607
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9,724,049
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Net
change in cash
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3,004,260
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1,400,622
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6,710,629
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Cash,
beginning of period
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3,706,369
|
542
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—
|
|||||||
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||||||||||
Cash,
end of period
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$
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6,710,629
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$
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1,401,164
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$
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6,710,629
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||||
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Supplemental
disclosure of cash flow information:
|
||||||||||
(Revaluation)
issuance of common stock and warrants to consulting firms for prepaid
consulting fees, net
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$
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(46,190
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)
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$
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—
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$
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503,810
|
|||
Conversion
of notes payable and accrued interest into common stock
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$
|
—
|
$
|
—
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$
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1,530,177
|
||||
Forgiveness
of notes payable and accrued interest to shareholders
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$
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—
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$
|
241,701
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$
|
241,701
|
||||
Conversion
of notes payable to shareholders
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$
|
—
|
$
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—
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$
|
196,300
|
4
(A
Development Stage Company)
NOTES
TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
Note
1. Business Description
Transdel
Pharmaceuticals, Inc. (“Transdel” or the “Company”) is a specialty
pharmaceutical company focused on the development and commercialization of
non-invasive topically delivered medications. The Company’s lead topical drug,
Ketotransdel TM,
utilizes the Company’s proprietary Transdel TM
cream
formulation to facilitate the passage of ketoprofen, a non-steroidal
anti-inflammatory drug (“NSAID”), through the skin barrier to reach targeted
underlying tissue where the drug exerts its prolonged localized
anti-inflammatory and analgesic effect. The Company is also investigating other
drug candidates and treatments for transdermal delivery using the Transdel
TM
platform
technology for products in pain management and other therapeutic
areas.
Note
2. Basis of Presentation
The
Company has prepared the accompanying unaudited condensed consolidated financial
statements in accordance with United States generally accepted accounting
principles (“GAAP”) for interim financial information and with the rules and
regulations of the Securities and Exchange Commission (the “SEC”) related to a
Quarterly Report on Form 10-Q and Article 8 of Regulation S-X. Accordingly,
they
do not include all of the information and disclosures required by GAAP for
annual financial statements. The consolidated financial statements
include the accounts of Transdel and its wholly owned subsidiary, Transdel
Pharmaceuticals Holdings, Inc. (formerly known as Trans-Pharma Corporation).
All
significant intercompany balances and transactions have been eliminated in
consolidation. In the opinion of the Company’s management, the accompanying
condensed consolidated financial statements contain all the adjustments
necessary (consisting only of normal recurring accruals) to make the financial
position of the Company as of June 30, 2008, the results of operations for
three
and six months ended June 30, 2008 and 2007, and cash flows for the six months
ended June 30, 2008 and 2007, fairly stated. The condensed consolidated
financial statements should be read in conjunction with the audited financial
statements for the year ended December 31, 2007 contained in Form
10-KSB filed on March 26, 2008 with the SEC. Interim operating results are
not
necessarily indicative of operating results for the full year.
Note
3. Merger with Public Company and Reorganization
On
September 17, 2007, Transdel entered into an Agreement of Merger and Plan of
Reorganization (the “Merger Agreement”) by and among Transdel, Transdel
Pharmaceuticals Holdings, Inc., a privately held Nevada corporation (“Transdel
Holdings”), and Trans-Pharma Acquisition Corp., a newly formed, wholly owned
Delaware subsidiary of Transdel (“Acquisition Sub”). Upon closing of the merger
transaction contemplated under the Merger Agreement (the “Merger”), Acquisition
Sub merged with and into Transdel Holdings, and Transdel Holdings, as the
surviving corporation, became a wholly owned subsidiary of
Transdel.
In
connection with the Merger, 1,849,993 shares of Transdel common stock remain
outstanding and all other outstanding shares of Transdel were cancelled. Also,
at the closing of the Merger, each share of Transdel Holdings common stock
issued and outstanding immediately prior to the closing of the Merger was
exchanged for the right to receive 0.15625 of one share of Transdel’s common
stock. An aggregate of 8,000,000 shares of Transdel’s common stock, which
included 195,313 shares of restricted stock which were subject to forfeiture
(see Note 7), were issued to the holders of Transdel Holdings’ common stock. As
a result of the transaction, the former owners of Transdel Holdings became
the
controlling stockholders of Transdel. Accordingly, the merger of Transdel
Holdings and Transdel is a reverse merger that has been accounted for as a
recapitalization of Transdel Holdings.
Effective
on September 17, 2007, and for all reporting periods thereafter, Transdel’s
operating activities, including any prior comparative period, will include
only
those of Transdel Holdings. All references to shares and per share amounts
in
the accompanying condensed consolidated financial statements have been restated
to reflect the aforementioned share exchange.
5
TRANSDEL
PHARMACEUTICALS, INC.
(A
Development Stage Company)
NOTES
TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
Note
4. Summary of Significant Accounting
Policies
Going
Concern.
The
accompanying unaudited condensed consolidated financial statements have been
prepared on a going-concern basis, which contemplates the realization of assets
and the satisfaction of liabilities in the normal course of business. The
Company has incurred recurring operating losses, had negative operating cash
flows and has not recognized any revenues since July 24,
1998 (“Inception”). In addition, the Company had an accumulated deficit
during the development stage of $8,613,579 at June 30, 2008. These factors
raise
substantial doubt about the Company’s ability to continue as a going
concern.
The
Company’s continuation as a going concern is dependent on its ability to obtain
additional financing to fund operations, implement its business model, and
ultimately, to attain profitable operations. The Company intends to obtain
additional financing to fund its operations through equity or debt financing
or
a corporate partnership for its lead topical drug, KetotransdelTM.
However, there is no assurance that sufficient financing will be available
or,
if available, on terms that would be acceptable to the Company.
The
unaudited condensed consolidated financial statements do not include any
adjustments relating to the recoverability and classification of recorded asset
amounts or the amounts and classification of liabilities that might be necessary
should the Company be unable to continue as a going concern.
Development
Stage Enterprise.
The
Company is a development stage company as defined in Statement of Financial
Accounting Standards (“SFAS”) No. 7, Accounting
and Reporting by Development Stage Enterprises.
The
Company is devoting substantially all of its present efforts to establish a
new
business, and its planned principal operations have not yet commenced. All
losses accumulated since Inception have been considered as part of the Company’s
development stage activities.
Research
and Development.
Research
and development costs are charged to expense when incurred.
Cash
and cash equivalents.
Cash
equivalents consist of highly liquid investments with maturities of three months
or less from the original purchase date.
Concentrations
of Credit Risk.
Financial instruments that potentially subject the Company to a concentration
of
credit risk consist primarily of cash and cash equivalents. In order to minimize
the Company’s risk related to the cash equivalents, they are maintained in a
money market demand account. Due to the short-term nature of this investment,
the Company believes that there is no material exposure to interest rate risk.
The Company maintains its cash and cash equivalents at a high-quality
institution that is insured by the Federal Deposit Insurance Corporation
(“FDIC”). At June 30, 2008, the Company had approximately $6,610,629 on deposit
in excess of the federally insured limit of $100,000. The Company performs
an
ongoing evaluation of this institution to limit its concentration of risk
exposure.
Fair
Value of Financial Instruments.
The fair
values of the Company’s cash and cash equivalents, accounts payable and accrued
expenses approximate their carrying values due to their short
maturities.
Beneficial
Conversion Feature.
The
convertible features of the convertible notes provided for a rate of conversion
that was below market value (see Note 5). Such feature is normally characterized
as a “beneficial conversion feature” (“BCF”). Pursuant to Emerging Issues Task
Force Issue (“EITF”) No. 98-5 Accounting
For Convertible Securities with Beneficial Conversion Features or Contingently
Adjustable Conversion Ratio,
and EITF
No. 00-27, Application
of EITF Issue No. 98-5 To Certain Convertible Instruments,
the
relative fair values of the BCFs have been recorded as a discount from the
face
amount of the respective debt instrument. The Company recorded the corresponding
debt discount related to the BCF as interest expense when the related instrument
was converted into the Company’s common stock.
6
TRANSDEL
PHARMACEUTICALS, INC.
(A
Development Stage Company)
NOTES
TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
Note
4. Summary of Significant Accounting Policies,
continued
Revenue
Recognition.
The
Company will recognize revenues in accordance with the SEC Staff Accounting
Bulletin (“SAB”) No. 101, Revenue
Recognition,
as
amended by SAB No. 104. SAB No. 104 requires that four basic criteria must
be
met before revenue can be recognized: (1) persuasive evidence of an arrangement
exists; (2) delivery has occurred; (3) the selling price is fixed and
determinable; and (4) collectibility is reasonably assured. Determination of
criteria (3) and (4) will be based on management’s judgments regarding the fixed
nature of the selling prices of the products delivered and the collectibility
of
those amounts. Provisions for discounts and rebates to customers, estimated
returns and allowances, and other adjustments will be provided for in the same
period the related sales are recorded. The Company will defer any revenue for
which the product has not been delivered or for which services have not been
rendered or are subject to refund until such time that the Company and the
customer jointly determine that the product has been delivered or services
have
been rendered or no refund will be required.
As
of
June 30, 2008, the Company had not generated any revenues and the Company does
not anticipate that it will generate any revenues until one or more of its
drug
candidates are approved by the U.S. Food and
Drug Administration (“FDA”) and effective sales and marketing support
are in place. The FDA approval process is highly uncertain and the Company
cannot estimate when it will generate revenues at this time.
Stock-Based
Compensation.
Effective January 1, 2006, the Company adopted SFAS No. 123 (revised
2004), Share-Based
Payment,
(‘‘SFAS
No. 123R’’), which is a revision of SFAS No. 123, Accounting
for Stock-Based Compensation.
SFAS
No. 123R supersedes Accounting Principles Board Opinion (“APB”) No. 25,
Accounting
for Stock Issued to Employees,
and
amends SFAS No. 95, Statement
of Cash Flows.
SFAS
123R requires all share-based payments to employees, including grants of
employee stock options and restricted stock grants, to be recognized in the
financial statements based upon their fair values. The Company recorded total
stock-based compensation of $412,089, $0 and $596,611 for the six months ended
June 30, 2008 and 2007 and for the period from Inception to June 30, 2008,
respectively, for options and restricted stock granted and vested which is
included in general and administrative expenses and research and development
expenses in the amount of $129,366 and $282,723, respectively, for the six
months ended June 30, 2008 and $192,945 and $403,666, respectively, for the
period from Inception to June 30, 2008. The fair value of the unvested stock
option grants amounted to approximately $885,000 as of June 30,
2008.
The
Company’s accounting policy for equity instruments issued to consultants and
vendors in exchange for goods and services follows the provisions of SFAS No.
123, EITF No. 96-18, Accounting
for Equity Instruments That are Issued to Other Than Employees for Acquiring,
or
in Conjunction with Selling, Goods or Services,
and EITF
No. 00-18, Accounting
Recognition for Certain Transactions Involving Equity Instruments Granted to
Other Than Employees.
As
such, the value of the applicable stock-based compensation is periodically
remeasured and income or expense is recognized during their vesting terms.
The
measurement date for the fair value of the equity instruments issued is
determined at the earlier of (i) the date at which a commitment for performance
by the consultant or vendor is reached or (ii) the date at which the consultant
or vendor’s performance is complete. In the case of equity instruments issued to
consultants, the fair value of the equity instrument is recognized over the
term
of the consulting agreement. In accordance with EITF No. 00-18, an asset
acquired in exchange for the issuance of fully vested, nonforfeitable equity
instruments should not be presented or classified as an offset to equity on
the
grantor’s balance sheet once the equity instrument is granted for accounting
purposes. Accordingly, the Company recorded the fair value of the common stock
issued for future consulting services as prepaid consulting fees in its
condensed consolidated balance sheets (see Note 6).
Basic
and Diluted Loss per Common Share.
In
accordance with SFAS No. 128, Earnings
Per Share,
and SAB
No. 98, basic net loss per common share is computed by dividing net loss for
the
period by the weighted average number of common shares outstanding during the
period. Under SFAS No. 128, diluted net loss per share is computed by
dividing the net loss for the period by the weighted average number of common
and common equivalent shares, such as stock options and warrants outstanding
during the period.
Basic
and
diluted net loss applicable to common stock per share is computed using the
weighted average number of common shares outstanding during the period. Common
stock equivalents (prior to application of the treasury stock, if converted
method) from stock options, warrants and convertible notes were 1,812,730 and
1,523,076 for the six months ended June 30, 2008 and 2007, respectively, are
excluded from the calculation of diluted net loss per share for all periods
presented because the effect is anti-dilutive.
7
TRANSDEL
PHARMACEUTICALS, INC.
(A
Development Stage Company)
NOTES
TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
Note
4. Summary of Significant Accounting Policies,
continued
Use
of Estimates.
The
preparation of financial statements in conformity with GAAP requires management
to make estimates and judgments that affect the reported amounts of assets,
liabilities and disclosure of contingent assets and liabilities at the date
of
the financial statements and reported amounts of revenues and expenses during
the reporting periods. Significant estimates made by management are, among
others, the valuation and realizability of contributed services, stock options,
deferred taxes and stock-based compensation issued to non-employees. Actual
results could differ from those estimates.
Note
5. Notes Payable
In
August
2005, the Company issued seven convertible promissory notes in the aggregate
amount of $226,300 to various stockholders (collectively the “Stockholders’
Notes”). The Stockholders’ Notes bore interest at 4% per annum and were to
mature on August 25, 2010. In connection with the issuance of the Stockholders’
Notes, the Company granted warrants that were exercisable into an aggregate
35,359 shares of the Company’s common stock. The warrants were determined to
have an insignificant fair value.
In
May
2007, the holders of the Stockholders’ Notes and related warrants forgave the
amounts due and forfeited the related warrants. In connection with the
forgiveness, the Company recorded additional paid-in capital of $241,701 equal
to the value of the Stockholders’ Notes and related accrued interest. Interest
expense on the Stockholders’ Notes was $3,150 and $15,401 for six months ended
June 30, 2007 and the period from Inception to June 30, 2008,
respectively.
In
May
and June 2007, the Company issued convertible notes payable to various lenders
for an aggregate amount of $1,500,000 (collectively, the “2007 Notes”). Each of
the 2007 Notes included interest at 7% per annum and were to mature on December
16, 2007 (“Maturity Date”). However, as a result of the Merger and Private
Placement (see Note 6), the entire outstanding principal amount and accrued
interest was converted into the Company’s common stock at a conversion price
equal to $1.00 per share, which resulted in the issuance of 1,530,177 shares.
Also, the Company recorded a debt discount of $1,530,177, which was amortized
immediately to interest expense upon the conversion of the 2007 Notes. Excluding
the debt discount, interest expense on the 2007 Notes was $7,451 and $30,177
for
the six months ended June 30, 2007 and the period from Inception to June 30,
2008.
Note
6. Stockholders’ Equity
On
May
12, 2008, the Company sold 1,818,180 shares of common stock for gross proceeds
of $4,000,000 through a follow-on private placement (the “Follow-on Private
Placement”) to accredited investors. In addition, the investors received
warrants to purchase 227,272 shares of common stock for a period of five years
at a cash and cashless exercise price of $4.40 and $5.50 per share,
respectively. In connection with the Follow-On Private Placement, the Company
incurred expenses of $22,470, which was recorded as a reduction of additional
paid-in capital.
Concurrent
with the Merger, the Company sold 2,071,834 shares of common stock for gross
proceeds of $4,143,667 through a private placement (the “Private Placement”). In
addition, the investors received warrants to purchase 517,958 shares of common
stock for a period of five years at a cash and cashless exercise price of $4.00
and $5.00 per share, respectively. In connection with the Private Placement,
the
Company incurred placement agent fees and other related expenses totaling
$342,105 of which $36,229 was incurred in 2008, and issued warrants to purchase
up to 33,750 shares of common stock for a period of three years at a cash and
cashless exercise price of $4.00 and $5.00 per share, respectively.
8
TRANSDEL
PHARMACEUTICALS, INC.
(A
Development Stage Company)
NOTES
TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
Note
6. Stockholders’ Equity (continued)
In
September 2007, the Company entered into three, one-year consulting agreements
with three separate firms to provide services related to investor
communications. The terms per one of the agreements, among other items, include
monthly payments of $7,500 plus expenses and for another agreement a
non-refundable fee of $140,000. Also, in the aggregate, 275,000 shares of common
stock were issued in accordance with the terms of the agreements along with
a
warrant to purchase 18,750 shares of common stock for a period of five years
at
a cash and cashless exercise price of $4.00 and $5.00, respectively. The fair
value of the stock and warrants were valued at $550,000. The estimated costs
of
the consulting agreements, including the stock, warrants and non-refundable
fee
are being amortized over the one-year terms.
In
accordance with EITF No. 00-18, 100,000 of the 275,000 shares of common stock
are subject to remeasurement on a periodic basis as the performance condition
for these shares is not satisfied until the end of the contract term. The
remeasurement for the 100,000 shares was completed in two stages. First, in
February 2008, the consulting agreement associated with these shares was
terminated and as a condition of the termination, the firm retained 50,000
shares and transferred the remaining 50,000 shares to another firm. Therefore,
since the performance obligation related to the 50,000 shares, retained by
the
terminated consulting firm, is complete, they were revalued as of the February
termination date to $60,000, which was the fair market value of the shares
on
the termination date. Second, the remaining 50,000 shares that were transferred
to the other firm will be utilized for the payment of investor communications
services to be provided through September 2008. In accordance with the related
agreement, the Company initially recorded the value of these shares at $100,000,
which was revalued at June 30, 2008 to $92,500 (the estimated fair market value
based on the closing market price). In the aggregate, the remeasurement of
the
50,000 shares earned and the transfer of the remaining 50,000 shares resulted
in
a reduction of additional paid in capital of $47,500 ($200,000 original value
less $152,500 remeasured value). For the six months ended June 30, 2008 and
2007
and for the period from Inception through June 30, 2008, the Company amortized
$303,807, $0 and $505,058, respectively, of prepaid consulting fees which
is included as part of selling, general and administrative
expenses.
On
April
24, 2008, the Company entered into a one-year consulting agreement with a firm
to provide the Company with financial advisory services. As compensation for
the
services, the Company issued a three-year warrant to purchase 5,000 shares
of
the Company’s common stock at a cash and cashless price of $2.00 per share. The
fair value of the warrant, determined based on the Black-Scholes pricing model,
was valued at $1,310, which is being amortized over the one-year
term.
Note
7. Stock Option Plans
On
September 17, 2007, the Company’s board of directors and stockholders adopted
the 2007 Incentive Stock and Awards Plan (the “Plan”), which provides for the
issuance of a maximum of 1,500,000 shares of Common Stock. The purpose of the
Plan is to provide an incentive to attract and retain directors, officers,
consultants, advisors and employees whose services are considered valuable,
to
encourage a sense of proprietorship and to stimulate an active interest of
such
persons into the Company’s development and financial success. Under the Plan,
the Company is authorized to issue incentive stock options intended to qualify
under Section 422 of the Code, non-qualified stock options and restricted stock.
The Plan will be administered by the Company’s Board of Directors until such
time as such authority has been delegated to a committee of the board of
directors.
Pursuant
to the terms of the Private Placement, for one year following the initial
closing of the Private Placement, the Company may not issue options to purchase
shares of common stock at an exercise price below $2.00 per share. In addition,
for a period of 18 months following the initial closing of the Private
Placement, the Company may not file a registration statement, including, without
limitation, a registration statement on Form S-8, covering the resale of any
shares of common stock issued pursuant to an employee benefit plan.
9
TRANSDEL
PHARMACEUTICALS, INC.
(A
Development Stage Company)
NOTES
TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
Note
7. Stock Option Plans,
continued
A
summary
of the status of the Plan for the six months ended June 30, 2008 is as
follows:
|
Number
of Shares
|
Weighted
Average
Exercise
Price
|
|||||
Options
outstanding – Beginning of Period
|
610,000
|
$
|
2.01
|
||||
Granted
|
600,000
|
2.00
|
|||||
Exercised
|
—
|
—
|
|||||
Cancelled
|
(200,000
|
)
|
(2.00
|
)
|
|||
Options
outstanding – End of Period
|
1,010,000
|
$
|
2.01
|
||||
Options
exercisable – End of Period
|
125,091
|
||||||
Weighted
average remaining contractual life of the outstanding options – End
of period
|
9.4
years
|
||||||
Aggregate
intrinsic value – End of Period
|
—
|
All
options granted to date expire on the ten year anniversary of the issuance
date
and vest on a quarterly basis over one to three years. The Company
uses the Black-Scholes option pricing model to estimate the grant-date fair
value of share-based awards under SFAS No. 123R. The Black-Scholes model
requires subjective assumptions regarding future stock price volatility and
expected time to exercise, along with assumptions about the risk-free interest
rate and expected dividends, which affect the estimated fair values of the
Company’s stock-based awards. The expected term of options granted was
determined in accordance with the simplified approach as defined by SAB No.
107,
Share-Based
Payment,
as the
Company has very limited historical data on employee exercises and post-vesting
employment termination behavior. The expected volatility is based on the
historical volatilities of the common stock of comparable publicly traded
companies based on the Company’s belief that it currently has limited historical
data regarding the volatility of its stock price on which to base a meaningful
estimate of expected volatility. The risk-free rate selected to value any
particular grant is based on the U.S. Treasury rate that corresponds to the
expected term of the grant effective as of the date of the grant. The Company
used 0% as an expected dividend yield assumption. These factors could change
in
the future, affecting the determination of stock-based compensation expense
in
future periods. Utilizing these assumptions, the fair value is determined at
the
date of grant. In accordance with SFAS No. 123R, the financial statement effect
of forfeitures is estimated at the time of grant and revised, if necessary,
if
the actual effect differs from those estimates. As of June 30, 2008,
management’s future estimates are that the effect of forfeitures on the
financial statements will be insignificant. As of June 30, 2008, there was
approximately $885,000 of total unrecognized compensation expense related to
unvested stock-based compensation under the Plan. That expense is expected
to be
recognized over the weighted-average period of 2.9 years.
Furthermore,
in August 2007, the Company issued a restricted stock grant to an executive
of
the Company for 195,313 shares of the Company’s common stock upon closing of the
Merger (See Note 3). The restricted stock grant was scheduled to vest 100%
on
March 17, 2009 and valued at approximately $391,000, which was being amortized
over the 18 month period. However, on April 4, 2008, the Company’s Board of
Directors waived any restrictions or forfeiture conditions on the shares of
restricted common stock in conjunction with the executive’s resignation and a
separation agreement entered into between the Company and the executive.
Therefore, the remaining unrecognized expense of $236,000 was fully amortized
as
a result of the waiver of the restrictions and forfeiture conditions.
10
TRANSDEL
PHARMACEUTICALS, INC.
(A
Development Stage Company)
NOTES
TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
Note
8. Stock Warrants
In
addition to the warrants issued in conjunction with the Private Placement and
the Follow-On Private Placement, the Company issued a warrant to purchase shares
of its common stock to a firm in connection with a consulting agreement at
an
exercise price of $4.00 (or cashless exercise price of $5.00). The expiration
of
the outstanding warrants occurs through May 2013 at various periods (see Note
6).
A
summary
of the status of the warrants for the period ended June 20, 2008, is as
follows:
Number of
Shares
Subject to
Warrants
Outstanding
|
Weighted-
Average
Exercise
Price
|
||||||
Warrants
outstanding – Beginning of Period
|
570,458
|
$
|
4.00
|
||||
Granted
|
232,272
|
4.35
|
|||||
Exercised
|
—
|
—
|
|||||
Expired
|
—
|
—
|
|||||
Warrants
outstanding – End of Period
|
802,730
|
$
|
4.10
|
||||
Weighted
average remaining contractual life of the outstanding warrants – End
of Period
|
4.32
years
|
Note
9. Recent Accounting Pronouncements
The
following pronouncements have been issued by the Financial Accounting Standards
Board (“FASB”):
In
December 2007, the FASB issued SFAS No. 141R, Business
Combinations.
SFAS
No. 141R provides companies with principles and requirements on how an acquirer
recognizes and measures in its financial statements the identifiable assets
acquired, liabilities assumed, and any noncontrolling interest in the acquiree
as well as the recognition and measurement of goodwill acquired in a business
combination. SFAS No. 141R also requires certain disclosures to enable users
of
the financial statements to evaluate the nature and financial effects of the
business combination. Acquisition costs associated with the business combination
will generally be expensed as incurred. SFAS No. 141R is effective for business
combinations occurring in fiscal years beginning after December 15, 2008. Early
adoption of SFAS No. 141R is not permitted. The Company is currently evaluating
the impact SFAS No. 141R will have on any future business
combinations.
Other
recent accounting pronouncements issued by the FASB (including the EITF) and
the
American Institute of Certified Public Accountants did not or are not believed
by management to have a material impact on the Company’s present or future
consolidated financial statements.
Note
10. Commitments and Contingencies
Indemnities
and Guarantees
The
Company has made certain indemnities and guarantees, under which it may be
required to make payments to a guaranteed or indemnified party, in relation
to
certain actions or transactions. The Company indemnifies its directors,
officers, employees and agents, as permitted under the laws of the State of
Delaware. The duration of the guarantees and indemnities varies, and is
generally tied to the life of the agreement. These guarantees and indemnities
do
not provide for any limitation of the maximum potential future payments the
Company could be obligated to make. Historically, the Company has not been
obligated nor incurred any payments for these obligations and, therefore, no
liabilities have been recorded for these indemnities and guarantees in the
accompanying unaudited condensed consolidated balance sheet as of June 30,
2008.
11
TRANSDEL
PHARMACEUTICALS, INC.
(A
Development Stage Company)
NOTES
TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
Note
10. Commitments and Contingencies (continued)
Mediation
Settlement
On
February 5, 2008, as a result of mediation, the Company and a previously
retained law firm reached an agreement related to certain alleged claims the
Company had against the law firm. Although the law firm did not admit to any
liability or wrongdoing, they desired to resolve the dispute and therefore,
agreed to pay the Company $750,000. In exchange for the settlement, the Company,
the law firm and any other parties involved in the mediation, released and
waived any future claims against each other, whether known or unknown at the
time of the settlement. The net amount received by the Company was $375,000
after fees paid to the Company’s counsel and an executive and director of the
Company. The fees paid to the executive and director, which were previously
approved by the Board of Directors, are due to their monetary contributions
and
uncompensated time commitment over a period of approximately four years related
to pursuing this matter and other amounts paid on the Company’s behalf prior to
the Merger.
Cato
Research Ltd. Agreement
In
accordance with the Master Services Agreement, dated April 10, 2007, between
the
Company and Cato Research Ltd., a contract research and development organization
(“Cato”), the Company entered into a clinical trial services agreement with Cato
on June 10, 2008 (“Agreement”). Under the Agreement, Cato will serve as the
Company’s strategic partner and contract research organization in conducting the
Company’s Phase 3 clinical program for Ketotransdel™, the Company’s novel
topical cream based non-steroidal anti-inflammatory drug for pain. Pursuant
to
the Agreement, the Company will make payments to Cato upon its completion of
certain specified milestones. If all milestones under the Agreement are
completed and the estimated pass-through costs are incurred, the Company’s total
costs under the Agreement are estimated at $3.3 million. In addition, any
changes to budget parameters identified in the Agreement may result in
additional costs to the Company. There can be no assurance that Cato will
complete its performance under the Agreement, and to the extent that such
performance is completed that the clinical trial results for Ketotransdel™ will
be satisfactory.
12
Overview
We
are a
specialty pharmaceutical company focused on the development and
commercialization of non-invasive topically delivered medications. Our lead
topical drug, Ketotransdel™, utilizes our proprietary Transdel™ cream
formulation to facilitate the passage of ketoprofen, a non-steroidal
anti-inflammatory drug (“NSAID”), through the skin barrier to reach targeted
underlying tissues where the drug exerts its localized anti-inflammatory and
analgesic effect. A Phase 1/2 clinical trial supported the safety and efficacy
of Ketotransdel™ for acute pain and muscle soreness.
Plan
of Operations
For
the next twelve months, our current operating plan is focused on the development
of our lead drug, Ketotransdel™ for the indication of acute musculoskeletal
pain. On June 16, 2008, we announced that we initiated our Phase 3 clinical
program for our novel analgesic and anti-inflammatory topical cream,
Ketotransdel™, which contains ketoprofen. The first Phase 3 study will consist
of a randomized, double-blind, placebo controlled trial to evaluate the efficacy
and safety of Ketotransdel™ in acute soft tissue injuries of the upper and lower
extremities over a one week treatment period with a one week post-treatment
follow-up for safety. The multi-center trial will be conducted at approximately
25 to 35 sites, mainly in the United States and potentially in Canada, and
will
enroll approximately 350 patients, randomized 1:1 ratio Ketotransdel™ (active)
versus placebo vehicle (identical to active without the drug ketoprofen). The
primary efficacy endpoint is the difference in the change of baseline of pain
during normal activity for the past 24 hours from measurement at the Day 3
clinical visit between active and placebo measured by using the Visual Analogue
Scale (VAS), a well known and validated instrument for pain measurement.
Secondary endpoints include safety assessments and other efficacy parameters
measured by VAS. As of July 31, 2008, we have initiated two study sites for
this
Phase 3 study. We would anticipate reporting top-line results in the second
half
of 2009. In addition, as required by the FDA, we will be initiating a second
Phase 3 clinical study in acute musculoskeletal pain, potentially for the
treatment of acute flare in osteoarthritis patients. We are currently assessing
the design and timing of this additional study that will support the
registration of Ketotransdel™ in the United States.
If
and
when the FDA approves Ketotransdel™ for treatment of acute pain, we intend
to pursue FDA approval of Ketotransdel™ for other indications. We believe that
the clinical success of Ketotransdel™ will facilitate the use of the Transdel™
delivery technology in other products. We are also investigating other
drug candidates and treatments for transdermal delivery using the Transdel™
platform technology for products in pain management and other therapeutic areas.
Furthermore, we are exploring potential partnerships with U.S. and foreign
based
companies that have sales and marketing infrastructures to support Ketotransdel™
in the event that the product is approved and commercialized. We are also
looking to out-license our Transdel™ drug delivery technology for the
development and commercialization of additional innovative drug products. In
addition, we are exploring opportunities in the cosmeceutical industry which
may
use our patented delivery technology. There can be no assurance that any of
these activities will lead to definitive agreements.
We
believe that our current staff is sufficient to carry out our business plan
in
the coming twelve months, however, if our operations in the future require
it, we will consider the employment of additional staff.
Liquidity
and Capital Resources
Since
July 24, 1998 (“Inception”) through June 30, 2008, we have incurred
losses of approximately $8.6 million. These losses are primarily due to general
and administrative and research and development expenses. Historically, our
operations have been financed through capital contributions and debt and equity
financings.
As
of
June 30, 2008, we had $6.7 million in cash. On each of September 17, 2007,
and
October 10, 2007, we completed private placements to selected institutional
and individual investors of our common stock and warrants. In connection
with the private placements, we raised approximately $3.8 million (net of
placement agent fees and other costs aggregating $342,105) from the issuance
of
2,071,834 shares of common stock and detachable redeemable warrants to purchase
517,958 shares of our common stock at a cash exercise price of $4.00 per share
and a cashless exercise price of $5.00 per share. In May 2008, we completed
another private placement to accredited investors, where we raised gross
proceeds of $4.0 million from the issuance of 1,818,180 shares of common stock
and detachable warrants to purchase 227,272 shares of our common stock at a
cash
exercise price of $4.40 per share and a cashless exercise price of $5.50 per
share.
We
are
assessing our financing needs for the foreseeable future. In order to
execute our operating plan over the next twelve months, which includes the
conduct of the Phase 3 clinical program, we will be required to raise additional
funds to support our operations. This funding requirement raises substantial
doubt about our ability to continue as a going concern. The accompanying
unaudited condensed consolidated financial statements have been prepared on
a
going-concern basis, which contemplates the realization of assets and the
satisfaction of liabilities in the normal course of business.
13
Our
continuation as a going concern is dependent on our ability to obtain additional
financing to fund operations, implement our business model, and ultimately,
to
attain profitable operations. We intend to obtain additional financing to fund
our operations through, and without limitation to, equity or debt
financing, funding from a corporate partnership or licensing arrangement or
any
similar financing. There can be no assurance that such financing will be
available on terms favorable to us or at all. If adequate financing is not
available, we will have to delay, postpone or terminate the clinical
program and curtail general and administrative operations, which would have
a
material adverse effect on us.
We
rely
on the use of estimates and make assumptions that impact our financial
condition and results. These estimates and assumptions are based on historical
results and trends as well as our forecasts as to how results and trends
might change in the future. Although we believe that the estimates we
use are reasonable, actual results could differ from those
estimates.
We
believe that the accounting policies described below are critical to
understanding our business, results of operations and financial condition
because they involve more significant judgments and estimates used in the
preparation of our unaudited condensed consolidated financial statements. An
accounting policy is deemed to be critical if it requires an accounting estimate
to be made based on assumptions about matters that are highly uncertain at
the
time the estimate is made, and any changes in the different estimates that
could
have been used in the accounting estimates that are reasonably likely to occur
periodically could materially impact our unaudited condensed consolidated
financial statements.
Stock-Based
Compensation.
Effective January 1, 2006, we adopted Statement of Financial
Accounting Standards (“SFAS”) No. 123 (revised 2004), Share-Based
Payment
,
(“SFAS No. 123R”), which is a revision of SFAS No. 123, Accounting
for Stock-Based Compensation
. SFAS
No. 123R supersedes Accounting Principles Board No. 25, Accounting
for Stock Issued to Employees,
and
amends SFAS No. 95, Statement
of Cash Flows.
SFAS
No. 123R requires all share-based payments to employees, including grants of
employee stock options and restricted stock grants, to be recognized in the
financial statements based upon their fair values. We use the Black-Scholes
option pricing model to estimate the grant-date fair value of share-based awards
under SFAS No. 123R. Fair value is determined at the date of grant. In
accordance with SFAS No. 123R, the financial statement effect of forfeitures
is
estimated at the time of grant and revised, if necessary, if the actual effect
differs from those estimates. As of June 30, 2008, management estimates that
the
effect of forfeitures on the unaudited condensed financial statements will
be
insignificant.
Our
accounting policy for equity instruments issued to consultants and vendors
in
exchange for goods and services follows the provisions of SFAS No. 123, Emerging
Issues Task Force (“EITF”) No. 96-18, Accounting
for Equity Instruments That are Issued to Other Than Employees for Acquiring,
or
in Conjunction with Selling, Goods or Services
and EITF
No. 00-18, Accounting
Recognition for Certain Transactions Involving Equity Instruments Granted to
Other Than Employees.
As such,
the value of the applicable stock-based compensation is periodically remeasured
and income or expense is recognized during the vesting terms. The measurement
date for the fair value of the equity instruments issued is determined at the
earlier of (i) the date at which a commitment for performance by the consultant
or vendor is reached or (ii) the date at which the consultant or vendor’s
performance is complete. In the case of equity instruments issued to
consultants, the fair value of the equity instrument is recognized over the
term
of the consulting agreement. In accordance with EITF No. 00-18, an asset
acquired in exchange for the issuance of fully vested, nonforfeitable equity
instruments should not be presented or classified as an offset to equity on
the
grantor’s balance sheet once the equity instrument is granted for accounting
purposes. Accordingly, we recorded the fair value of the common stock
issued for future consulting services as prepaid consulting fees in our
unaudited condensed consolidated balance sheet.
Beneficial
Conversion Feature.
The
convertible features of the convertible notes provided for a rate of conversion
that was below market value (see Note 5). Such feature is normally characterized
as a “beneficial conversion feature” (“BCF”). Pursuant to EITF No. 98-5
Accounting
For Convertible Securities with Beneficial Conversion Features or Contingently
Adjustable Conversion Ratio
and EITF
No. 00-27, Application
of EITF Issue No. 98-5 To Certain Convertible Instruments,
the
relative fair values of the BCFs have been recorded as a discount from the
face
amount of the respective debt instrument. We recorded the corresponding
debt discount related to the BCF as interest expense, in fiscal year 2007,
when
the related instrument was converted into its common
stock.
14
Off-Balance
Sheet Arrangements
Since our
inception, except for standard operating leases, we have not engaged
in any off-balance sheet arrangements, including the use of structured finance,
special purpose entities or variable interest entities.
In
December 2007, the FASB issued SFAS No. 141R, Business
Combinations
. SFAS
No. 141R provides companies with principles and requirements on how an acquirer
recognizes and measures in its financial statements the identifiable assets
acquired, liabilities assumed, and any noncontrolling interest in the acquiree
as well as the recognition and measurement of goodwill acquired in a business
combination. SFAS No. 141R also requires certain disclosures to enable users
of
the financial statements to evaluate the nature and financial effects of the
business combination. Acquisition costs associated with the business combination
will generally be expensed as incurred. SFAS No. 141R is effective for business
combinations occurring in fiscal years beginning after December 15, 2008. Early
adoption of SFAS No. 141R is not permitted. We are currently evaluating the
impact SFAS No. 141R will have on any future business combinations.
We
maintain
disclosure controls and procedures that are designed to ensure that information
required to be disclosed in our reports under the Exchange Act is recorded,
processed, summarized and reported within the time periods specified in the
Commission’s rules and forms and that such information is accumulated and
communicated to our management, including our Chief Executive Officer
and Chief Financial Officer, as appropriate, to allow for timely decisions
regarding required disclosure. In designing and evaluating the disclosure
controls and procedures, management recognizes that any controls and procedures,
no matter how well designed and operated, can provide only reasonable assurance
of achieving the desired control objectives, and management is required to
apply
its judgment in evaluating the cost-benefit relationship of possible controls
and procedures.
As
required by Commission Rule 13a-15(b), we carried out an evaluation, under
the supervision and with the participation of our management, including our
Chief Executive Officer and the Chief Financial Officer, of the effectiveness
of
the design and operation of our disclosure controls and procedures as of
the end of the quarter covered by this quarterly report on Form 10-Q. Based
on
the foregoing, our Chief Executive Officer and Chief Financial Officer
concluded that our disclosure controls and procedures were effective at the
reasonable assurance level.
There
has
been no change in our internal control over financial reporting
during our most recent fiscal quarter that has materially affected, or is
reasonably likely to materially affect, our internal control over financial
reporting.
15
OTHER
INFORMATION
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds
Except
as
previously included in our Current Reports on Form 8-K filed with the
Securities and Exchange Commission on May 15, 2008, we have not sold any
equity securities during the period covered by this quarterly report on Form
10-Q that were not registered under the Securities Act of 1933, as
amended.
Item
6. Exhibits
Exhibit
Number
|
|
Description
|
|
|
|
10.1*
|
Clinical
Trial Services Agreement by and between Transdel Pharmaceuticals,
Inc. and
Cato Research Ltd.
|
|
31.1*
|
|
Section
302 Certification of Principal Executive Officer
|
31.2*
|
|
Section
302 Certification of Principal Financial Officer
|
32.1*
|
|
Section
906 Certification of Principal Executive Officer and Principal Financial
Officer
|
______________________
*
|
Filed
herewith.
|
16
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.
Transdel
Pharmaceuticals, Inc.
|
||
|
|
|
Dated:
August 11, 2008
|
By: | /s/ Juliet Singh |
Juliet
Singh, Ph.D.
Chief
Executive Officer
(Principal
Executive Officer)
|
||
17
Exhibit
Number
|
|
Description
|
|
|
|
10.1*
|
Clinical
Trial Services Agreement by and between Transdel Pharmaceuticals,
Inc. and
Cato Research Ltd.
|
|
31.1*
|
|
Section
302 Certification of Principal Executive Officer
|
31.2*
|
|
Section
302 Certification of Principal Financial Officer
|
32.1*
|
|
Section
906 Certification of Principal Executive Officer and Principal
Financial
Officer
|
______________________
*
|
Filed
herewith.
|