Urigen Pharmaceuticals, Inc. - Quarter Report: 2007 September (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM 10-Q
ý Quarterly
report pursuant to Section 13 or 15(d) of the Securities Exchange Act
of 1934.
For
the quarterly period ended September 30, 2007.
or
o
Transition report pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934.
For
the transition period from
to
Commission
File Number 0-22987
(Exact
Name of Registrant as Specified in Its Charter)
Delaware
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94-3156660
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(State
or Other Jurisdiction of Incorporation or
Organization)
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(IRS
Employer Identification No.)
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|
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875
Mahler Road, Suite 235, Burlingame, CA
|
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94010
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(Address
of Principal Executive Offices)
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(Zip
Code)
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(650) 259-0239
(Registrant’s
Telephone Number Including Area Code)
Indicate
by check mark whether the registrant (1) has filed all reports required 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 ý No
o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer or a non-accelerated filer. See definition of “accelerated
filer and large accelerated filer” in Rule 12b-2 of the Exchange
Act.
Large
Accelerated Filer o
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|
Accelerated
Filer o
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Non-accelerated
Filer ý
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Indicate
by check mark whether the registrant is a shell company (as defined in
Rule 12b-2 of the Exchange Act). Yes o No
ý
The
number of outstanding shares of the registrant’s Common Stock, $0.001 par value,
was 68,329,817 as of November 13, 2007.
URIGEN
PHARMACEUTICALS, INC.
INDEX
PART
I: FINANCIAL INFORMATION
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ITEM
1:
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FINANCIAL
STATEMENTS (Unaudited)
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3
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Condensed
Consolidated Balance Sheets
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3
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|
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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 the 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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16
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Overview
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16
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Results
of Operations
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18
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Liquidity
and Capital Resources
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19
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ITEM
3 :
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QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
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20
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ITEM
4:
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CONTROLS
AND PROCEDURES
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20
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PART
II: OTHER INFORMATION
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21
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||
Item
1
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Legal
Proceedings
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|||
ITEM
1A :
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RISK
FACTORS
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21
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ITEM
2
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UNREGISTERED
SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
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21
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|||
ITEM
3
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DEFAULTS
UPON SENIOR SECURITIES
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21
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|||
ITEM
4
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SUBMISSION
OF MATTERS TO A VOTE OF SECURITY HOLDERS
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21
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|||
ITEM
5
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OTHER
INFORMATION
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21
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ITEM
6:
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EXHIBITS
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21
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SIGNATURES
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22
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2
PART
I: FINANCIAL INFORMATION
URIGEN
PHARMACEUTICALS,
INC.
(a
development stage enterprise)
CONDENSED
CONSOLIDATED BALANCE SHEETS
Unaudited
ASSETS
September
30, 2007
|
June
30, 2007
|
|||||||
Current
assets:
|
||||||||
Cash
|
$ |
918,745
|
$ |
101,608
|
||||
Other
current assets
|
307,265
|
21,204
|
||||||
Total
current assets
|
1,226,010
|
122,812
|
||||||
Fixed
assets, net
|
9,201
|
4,526
|
||||||
Intangible
assets, net
|
255,902
|
259,509
|
||||||
Other
assets
|
-
|
1,024
|
||||||
Total
assets
|
$ |
1,491,113
|
$ |
387,871
|
LIABILITIES
AND STOCKHOLDERS' (DEFICIT)
Current
liabilities:
|
||||||||
Account
payable
|
$ |
470,657
|
$ |
693,217
|
||||
Accrued
expenses
|
763,258
|
385,341
|
||||||
Series
B convertible preferred stock liability
|
2,100,000
|
-
|
||||||
Series
B convertible preferred stock beneficial conversion
feature
|
972,443
|
-
|
||||||
Due
to related parties
|
153,317
|
226,068
|
||||||
Notes
payable - related party
|
476,000
|
300,000
|
||||||
Total
current liabilities
|
4,935,675
|
1,604,626
|
||||||
Stockholders'
(deficit):
|
||||||||
Series
B convertible preferred stock, par value $0.00001, 1,000,000
shares
authorized and 534,703
shares
issued and outstanding at June 30, 2007
(Liquidation
Preference: $1,336,757 at June 30, 2007)
|
-
|
1,336,757
|
||||||
Common
stock, par value $0.001 and $0.00001 at September 30, 2007 and June
30, 2007, respectively, 190,000,000 and 20,000,000 shares
authorized
and 68,289,535 and 19,865,428 shares issued and outstanding at
September
30, 2007 and June
30, 2007, respectively
|
68,290
|
199
|
||||||
Stock
subscribed
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-
|
79,073
|
||||||
Additional
paid-in capital
|
4,584,469
|
2,139,864
|
||||||
Accumulated
other comprehensive income
|
21,312
|
19,800
|
||||||
Deficit
accumulated during the development stage
|
(8,118,633 | ) | (4,792,448 | ) | ||||
Total
stockholders' (deficit)
|
(3,444,562 | ) | (1,216,755 | ) | ||||
Total
liabilities and stockholders' (deficit)
|
$ |
1,491,133
|
$ |
387,871
|
See
accompanying notes.
3
URIGEN
PHARMACEUTICALS,
INC.
(a
development stage enterprise)
CONDENSED
CONSOLIDATED STATEMENTS OF
OPERATIONS
for
the three months ended September 30, 2007 and 2006
and for the period from July 18, 2005 (date of inception) to September 30,
2007
Unaudited
Operating
expenses:
|
Three
Months Ended September
30, 2007
|
Three
Months Ended September 30, 2006
|
Cumulative
period
from
July 18, 2005
(date
of inception) to September 30, 2007
|
||||||||||
Research
and development
|
$ |
156,081
|
$ |
414,055
|
$ |
1,718,116
|
|||||||
General
and administrative
|
1,000,188
|
218,501
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3,814,280
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||||||||||
Sales
and marketing
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52,564
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13,805
|
359,631
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||||||||||
Total
operating expenses
|
1,208,833
|
646,361
|
5,892,027
|
||||||||||
Loss
from operations
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(1,208,833 | ) | (646,361 | ) | (5,892,027 | ) | |||||||
Other
income and expense, net:
|
|||||||||||||
Interest
income
|
9,348
|
3,812
|
31,699
|
||||||||||
Interest
expense
|
(2,128,951 | ) | (64 | ) | (2,230,350 | ) | |||||||
Other
income
|
2,251
|
-
|
2,251
|
||||||||||
Exchange
loss
|
-
|
-
|
(30,206 | ) | |||||||||
Total
other income and expense, net
|
(2,117,352 | ) |
3,748
|
(2,226,606 | ) | ||||||||
Net
loss
|
$ |
(3,326,185)
|
$ | (642,613 | ) | $ | (8,118,633 | ) | |||||
Basic
and diluted net loss per share
|
$ |
(0.05)
|
$ | (0.04 | ) | ||||||||
Shares
used in computing basic and diluted net loss per common
share
|
61,607,794
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15,368,471
|
|
See
accompanying notes.
4
URIGEN
PHARMACEUTICALS,
INC.
(a
development stage enterprise)
CONDENSED
CONSOLIDATED STATEMENTS OF CASH
FLOWS
for
the three months ended September 30, 2007 and 2006
and for the period from July 18, 2005 (date of inception) to September 30,
2007
Unaudited
Cash
flows from operating activities:
|
Three Months
Ended September 30, 2007
|
Three Months
Ended September 30, 2006
|
Cumulative
period from July 18, 2005 (date of inception) to September 30,
2007
|
|||||||||
Net
loss
|
$ | (3,326,185 | ) | $ | (642,613 | ) | $ | (8,118,633 | ) | |||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Depreciation
of fixed assets
|
748
|
748
|
3,003
|
|||||||||
Amortization
of intangible assets
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3,607
|
3,607
|
22,735
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|||||||||
Stock
compensation expensed
|
10,740
|
-
|
10,740
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|||||||||
Non-cash
expenses: compensation, interest, rent, and other
|
10,000
|
37,717
|
1,292,110
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|||||||||
Preferred
Series B discount and imputed interest
|
2,117,500
|
-
|
2,117,500
|
|||||||||
Changes
in operating assets and liabilities:
|
||||||||||||
Prepaid
expenses and other assets
|
(68,431 | ) |
-
|
(85,659 | ) | |||||||
Due
from stockholders
|
-
|
10,000
|
-
|
|||||||||
Accounts
payable
|
(222,560 | ) |
206,659
|
470,657
|
||||||||
Accrued
expenses
|
43,784
|
79,015
|
429,125
|
|||||||||
Amounts
due to related parties
|
(72,751 | ) | (14,175 | ) |
153,317
|
|||||||
Net
cash used in operating activities
|
(1,503,548 | ) | (319,042 | ) | (3,705,105 | ) | ||||||
Cash
flows from investing activities:
|
||||||||||||
Purchases
of fixed assets
|
(926 | ) |
-
|
(7,707 | ) | |||||||
Asset-based
purchase, net of cash acquired, from Urigen, Inc.
|
-
|
-
|
470,000
|
|||||||||
Net
cash provided by investing activities
|
(926 | ) |
-
|
462,293
|
||||||||
Cash
flows from financing activities:
|
||||||||||||
Cash
acquired in consumation of reverse merger
|
220,099
|
-
|
220,099
|
|||||||||
Proceeds
from issuance of notes payable related party
|
-
|
-
|
300,000
|
|||||||||
Payment
of receivables from shareholders
|
-
|
-
|
45,724
|
|||||||||
Proceeds
from common stock subscribed
|
-
|
-
|
6,752
|
|||||||||
Proceeds
from issuance of Series B convertible preferred stock, net of issuance
costs
|
-
|
-
|
415,000
|
|||||||||
Proceeds
from issuance of Series A convertible preferred stock, net
|
-
|
-
|
1,002,135
|
|||||||||
Proceeds
from preferred stock
|
2,100,000
|
-
|
2,100,000
|
|||||||||
Proceeds
from issuance of common stock
|
-
|
8,271
|
-
|
|||||||||
Proceeds
from exercise of stock options and common stock subscribed
|
-
|
2,251
|
8,558
|
|||||||||
Net
cash provided by financing activities
|
2,320,099
|
10,522
|
4,098,268
|
|||||||||
Effect
of exchange rate changes on cash
|
1,512
|
2,922
|
63,289
|
|||||||||
Net
increase (decrease) in cash
|
817,137
|
(305,598 | ) |
918,745
|
||||||||
Cash,
beginning of period
|
101,608
|
567,489
|
-
|
|||||||||
Cash,
end of period
|
$ |
918,745
|
$ |
261,891
|
$ |
918,745
|
See
accompanying notes.
5
URIGEN
PHARMACEUTICALS, INC.
(a
development stage enterprise)
1.
|
Organization
and Basis of Presentation
|
The
accompanying condensed consolidated financial statements are unaudited and
have
been prepared by Urigen Pharmaceuticals, Inc. (“Urigen,” the “Company,”
“we,” “us” or “our”) in accordance with the rules and regulations of the
Securities and Exchange Commission for interim financial information and in
accordance with the instructions to Form 10-Q and Article 10 of
Regulation S-X. Certain information and footnote disclosures normally
included in the Company’s annual consolidated financial statements as required
by accounting principles generally accepted in the United States have been
condensed or omitted. The interim condensed consolidated financial statements,
in the opinion of management, reflect all adjustments (consisting of normal
recurring accruals) necessary for a fair statement of financial position at
September 30, 2007 and the results of operations for the interim
periods ended September 30, 2007 and 2006 and for the cumulative
period from July 18, 2005 (date of inception) to September 2007.
The
results of operations for the three months ended September 30, 2007 are not
necessarily indicative of the results of operations to be expected for the
fiscal year, although Urigen expects to incur a substantial loss for the year
ended June 30, 2008. These interim condensed consolidated financial
statements should be read in conjunction with the audited consolidated financial
statements for the fiscal year ended June 30, 2007, which are
contained in Urigen’s Annual Report on Form 10-K filed with the Securities
and Exchange Commission.
The
accompanying condensed consolidated financial statements include the accounts
of
Valentis, Inc. and its wholly-owned subsidiaries, Urigen N.A., Inc. and PolyMASC
Pharmaceuticals plc. All significant inter-company balances and transactions
have been eliminated.
6
URIGEN
PHARMACEUTICALS, INC.
(a
development stage enterprise)
The
accompanying unaudited consolidated financial statements have been prepared
assuming that the Company will continue as a going concern and have been
presented on a basis that contemplates the realization of assets and
satisfaction of liabilities in the normal course of business.
2.
|
Significant
Accounting Policies
Liquidity
|
The
Company’s financial statements have been prepared on a going concern basis,
which contemplates the realization of assets and the settlement of liabilities
and commitments in the normal course of business. Since inception through
September 30, 2007, the Company has accumulated net losses of $8,118,633 and
negative cash flows from operations of $3,705,105 and has a negative working
capital of $3,709,665. Management expects to incur further losses for the
foreseeable future. The Company expects to finance future cash needs primarily
through proceeds from equity or debt financings, loans, and/or collaborative
agreements with corporate partners in order to be able to sustain its operations
until the Company can achieve profitability and positive cash flows, if ever.
Management plans to seek additional debt and/or equity financing for the Company
through private or public offerings, but it cannot assure that such financing
will be available on acceptable terms, or at all. These matters raise
substantial doubt about the Company’s ability to continue as a going concern.
The accompanying financial statements do not include any adjustments that might
result from the outcome of this uncertainty.
Use
of Estimates
The
preparation of financial statements in accordance with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities at the date of the financial statements, the reported amounts of
expenses during the reporting period, and amounts disclosed in the notes to
the
financial statements. Actual results could differ from those
estimates.
7
URIGEN
PHARMACEUTICALS, INC.
(a
development stage enterprise)
Foreign
Currency
The
functional currency of the Company until October 4, 2006 was the Canadian
dollar (local currency). Starting on October 5, 2006, the functional
currency is the U.S. dollar (local currency). The transactions from date of
inception through October 4, 2006 in these financial statements and notes to
the
financial statements of the Company have been translated into U.S. dollars
using period-end exchange rates for assets and liabilities,
and
monthly average exchange rates for expenses. Intangible assets and equity are
translated at historical exchange rates. Translation gains and losses are
deferred and recorded in accumulated other comprehensive income (loss) as a
component of stockholders’ (deficit).
Transaction
gains and losses that arise from exchange rate changes denominated in other
than
the local currency are included in other expenses in the statement of operations
and are not considered material for the period presented.
Fair
Value of Financial Instruments
The
carrying amounts of certain of the Company’s financial instruments including
cash, due from stockholders, prepaid expenses, notes payable, accounts payable,
accrued expenses, and due to related parties approximate fair value due to
their
short maturities.
Cash
Concentration
At
September 30, 2007, the Company had $806,054 in bank balances at a single U.S.
financial institution in excess of the Federal Deposit Insurance Corporation
coverage limit of $100,000. At September 30, 2006, the Company had
$214,338 (in US dollars) in bank balances at a single Canadian financial
institution in excess of the Canada Deposit Insurance Corporation coverage
limit
of 100,000 Canadian dollars.
Intangible
Assets
Intangible
assets include the intellectual property and other patented rights acquired.
Consideration paid in connection with acquisitions is required to be allocated
to the acquired assets, including identifiable intangible assets, and
liabilities acquired. Acquired assets and liabilities are recorded based on
the
Company’s estimate of fair value, which requires significant judgment with
respect to future cash flows and discount rates. For intangible assets other
than goodwill, the Company is required to estimate the useful life of the asset
and recognize its cost as an expense over the useful life. The Company uses
the
straight-line method to expense long-lived assets (including identifiable
intangibles). The intangible assets were recorded based on their estimated
fair
value and are being amortized using the straight-line method over the estimated
useful life of 20 years, which is the life of the intellectual property
patents.
Impairment
of Long-Lived Assets
The
Company regularly evaluates its business for potential indicators of impairment
of intangible assets. The Company’s judgments regarding the existence of
impairment indicators are based on market conditions, operational performance
of
the business and considerations of any events that are likely to cause
impairment. Future events could cause the Company to conclude that impairment
indicators exist and that intangible assets are impaired. The Company currently
operates in one reportable segment, which is also the only reporting unit for
the purposes of impairment analysis.
The
Company evaluates its long-lived assets for indicators of possible impairment
by
comparison of the carrying amounts to future net undiscounted cash flows
expected to be generated by such assets when events or changes in circumstances
indicate the carrying amount of an asset may not be recoverable.
Should
8
URIGEN
PHARMACEUTICALS, INC.
(a
development stage enterprise)
an
impairment exist, the impairment loss would be measured based on the excess
carrying value of the asset over the asset’s fair value or discounted estimates
of future cash flows. The Company has not identified any such impairment losses
to date.
Income
Taxes
Income
taxes are recorded under the balance sheet method, under which deferred tax
assets and liabilities are determined based on the difference between the
financial statement and tax bases of assets and liabilities using enacted tax
rates in effect for the year in which the differences are expected to affect
taxable income. Valuation allowances are established when necessary to reduce
deferred tax assets to the amount expected to be realized.
Research
and Development
Research
and development expenses include clinical trial costs, outside consultants
and
contractors, and insurance for the Company’s research and development
activities. The Company recognizes such costs as expense when they are
incurred.
Comprehensive
Income (Loss)
The
Company reports comprehensive income (loss) in accordance with the provisions
of
Statement of Financial Accounting Standards No. 130, Reporting Comprehensive
Income, which establishes standards for reporting comprehensive income
(loss) and its components in the financial statements. The components of other
comprehensive income (loss) consists of net loss and foreign currency
translation adjustments. Comprehensive income (loss) and the components of
accumulated other comprehensive income (loss) are presented in the accompanying
statement of stockholders’ equity (deficit).
Three
Months
Ended
September
30, 2007
|
Period
from
July
18,2005
(date
of inception) to
September
30, 2007
|
|||||||
Net
loss
|
$ | (3,326,185 | ) | $ | (8,118,663 | ) | ||
Foreign
currency translation adjustments, net of tax
|
1,512
|
21,312
|
||||||
Comprehensive
loss
|
$ | (3,324,673 | ) | $ | (8,097,351 | ) |
Stock-Based
Compensation
The
Company accounts for stock-based compensation in accordance with Statement
of
Financial Accounting Standards No. 123 (revised 2004), Share-Based
Payment (“SFAS 123R”), which requires the measurement of all
share-based payments to employees, including grants of stock options, using
a
fair-value-based method and the recording of such expense in the statement
of
operations for all share-based payment awards made to employees and directors
including employee stock options based on estimated fair values. In addition,
as
required by Emerging Issues Task Force Consensus No. 96-18, Accounting
for Equity Instruments That Are Issued to Other Than Employees for Acquiring,
or
in Conjunction with Selling Goods or Services, the Company records stock
and options granted at fair value of the consideration received or the fair
value of the equity investments issued as they vest over a performance
period.
Recent
Accounting Pronouncements
In
September 2006, the FASB issued FASB Statement No. 157, “Fair Value
Measurements,” or SFAS 157. The standard provides guidance for using fair
value to measure assets and liabilities. The
9
URIGEN
PHARMACEUTICALS, INC.
(a
development stage enterprise)
standard
also responds to investors’ requests for expanded information about the extent
to which companies measure assets and liabilities at fair value, the information
used to measure fair value, and the effect of fair value measurements on
earnings. The standard applies whenever other standards require or permit assets
or liabilities to be measured at fair value. The standard does not expand the
use of fair value in any new circumstances. SFAS 157 must be adopted
prospectively as of the beginning of the year it is initially applied.
SFAS 157 is effective for financial statements issued for fiscal years
beginning after November 15, 2007, and interim periods within those fiscal
years. We are still evaluating the impact of this standard will have on our
financial position or results of operations.
In
February 2007, the FASB issued Statement of Financial Accounting Standards
No.
159, “The Fair Value Option for Financial Assets and Liabilities”
(“SFAS 159”). SFAS 159 provides entities with the option to report selected
financial assets and liabilities at fair value. Business entities adopting
SFAS
159 will report unrealized gains and losses in earnings at each subsequent
reporting date on items for which fair value option has been elected. SFAS
159
establishes presentation and disclosure requirements designed to facilitate
comparisons between entities that choose different measurement attributes for
similar types of assets and liabilities. SFAS 159 requires additional
information that will help investors and other financial statement users to
understand the effect of an entity’s choice to use fair value on its earnings.
SFAS 159 is effective for fiscal years beginning after November 15, 2007, with
earlier adoption permitted. The Company is currently assessing the impact that
the adoption of SFAS 159 may have on its financial position, results of
operations or cash flows.
In
June
2006, the Financial Accounting Standards Board (“FASB”) issued FASB
Interpretation No. 48, “Accounting for Uncertainty in Income Taxes —
an interpretation of FASB Statement No. 109” (FIN 48). FIN 48
prescribes a recognition threshold and measurement attribute for financial
statement recognition and measurement of a tax position taken or expected to
be
taken in a tax return, and also provides guidance on derecognition,
classification, interest and penalties, accounting in interim periods,
disclosure, and transition. FIN 48 is effective for fiscal years beginning
after December 15, 2006. We adopted the provisions of FIN 48 on
July 1, 2007. As a result of the implementation of FIN 48, we
recognized no material adjustments in the liability for unrecognized income
tax
benefits. At the adoption date we did not have any unrecognized tax
benefits and did not have any interest or penalties accrued. The cumulative
effect of this change was not material. Following implementation, the
ongoing changes in measurement of uncertain tax provisions will be reflected
as
a component of income tax expense. Interest and penalties incurred
associated with unresolved tax positions will continue to be included in other
income (expense).
3.
|
Intangible
Assets and Related Agreement Commitments/
Contingencies
|
In
January 2006, the Company entered into an asset-based transaction agreement
with
a related party, Urigen, Inc. Simultaneously, the Company entered into a license
agreement with a University for certain patent rights.
The
agreement with the University was for a license previously licensed to Urigen,
Inc. In exchange for this license, the Company issued 818,646 common shares
and
is required to make annual maintenance payments of $15,000 and milestone
payments of up to $625,000, which are based on certain events related to FDA
approval. As of September 30, 2007, $25,000 of milestone payments have been
incurred. The Company is also required to make royalty payments of 1.5% -3.0
%
of net sales of licensed products, with a minimum annual royalty of $35,000.
The
term of the agreement ends on the earlier of the expiration of the longest-lived
item of the patent rights or the tenth anniversary of the first commercial
sale.
Either party may terminate the license agreement for cause in the event that
the
other party commits a material breach and fails to cure such breach. In
addition, Urigen may terminate the license agreement at any time and for any
reason upon a 90-day written notice.
10
URIGEN
PHARMACEUTICALS, INC.
(a
development stage enterprise)
The
Company’s agreement with Urigen, Inc. included an assignment of a patent
application and intellectual property rights associated therein, and the
transfer of other assets and liabilities of Urigen, Inc., resulting in the
recognition of intangible assets, as follows:
Cash
|
$ |
350,000
|
||
Receivable
from Urigen, Inc.
(collected
during the period ended June 30, 2006)
|
120,000
|
|||
Expenses
paid on behalf of the Company
|
76,923
|
|||
Convertible
debt
|
(255,000 | ) | ||
Subscription
agreements for preferred shares
|
(480,000 | ) | ||
Other
|
(560 | ) | ||
Net
intangible assets acquired
|
$ |
188,637
|
In
May
2006, the Company entered into a license agreement with Kalium, Inc., for patent
rights and technology relating to suppositories for use in the genitourinary
or
gastrointestinal system and for the development and utilization of this
technology to commercialize products. Under the terms of the agreement, the
Company issued common stock in the amount of 720,000 shares (with an estimated
fair value of $90,000) and shall pay Kalium royalties based on percentages
of
2.0-4.5% of net sales of licensed products during the defined term of the
agreement. The Company also is required to make milestone payments (based on
achievement of certain events related to FDA approval) of up to $457,500.
Milestone payments may be made in cash or common stock, at the Company’s
discretion. Kalium shall have the right to terminate rights under this license
agreement or convert the license to non-exclusive rights if the Company fails
to
meet certain milestones over the next three years.
The
summary of intangible assets acquired and related accumulated amortization
as of
September 30, 2007 is as follows:
Patent
and intellectual property rights
|
$ |
278,637
|
||
Less:
Accumulated amortization
|
(22,735 | ) | ||
Intangible
assets, net
|
$ |
255,902
|
Purchased
intangible assets are carried at cost less accumulated amortization.
Amortization is computed over the estimated useful lives of the assets, with
a
weighted average amortization period of 20 years. The Company reported
amortization expense on purchased intangible assets of $14,428 and $4,700
for the quarters ended September 30, 2007 and 2006, respectively, which is
included in research and development expense in the accompanying statements
of
operations. Future estimated amortization expense is as follows:
October
1, 2007 – September 30, 2008
|
$ |
14,428
|
||
October
1, 2008 – September 30, 2009
|
14,428
|
|||
October
1, 2009 – September 30, 2010
|
14,428
|
|||
October
1, 2010 – September 30, 2011
|
14,428
|
|||
October
1, 2011 – September 30, 2012
|
14,428
|
|||
Thereafter
|
183,762
|
|||
$ |
255,902
|
11
URIGEN
PHARMACEUTICALS, INC.
(a
development stage enterprise)
4.
|
Notes
Payable – related party
|
On
November 17, 2006, the Company entered into an unsecured promissory note with
a
director of the Company, in the amount of $200,000. Under the terms of the
note,
the Company is to pay interest at a rate per annum computed on the basis of
a
360-day year equal to 12% simple interest. The foregoing amount is due and
payable on the earlier of (i) forty-five (45) days after consummation of the
Merger (as defined in the Agreement and Plan of Merger, dated as of October
5,
2006, between the Company and Valentis, Inc., or (ii) two (2) calendar years
from the note issuance date (in either case, the “Due Date”)). Also, the Company
issued 1,000 shares of Series B Preferred Stock, par value $0.00001 per share,
in connection with this note agreement.
On
January 5, 2007, the Company entered into an unsecured promissory note with
a
related party in the amount of $100,000. Under the terms of the note, the
Company is to pay interest at a rate of 12% per annum until paid in full, with
interest compounded as additional principal on a monthly basis if said interest
is not paid in full by the end of each month. Interest shall be computed on
the
basis of a 360 day year. All amounts owed by borrower to Lender hereunder are
due and payable by Borrower at its option, without notice or demand, on the
earlier of (i) ninety (90) days after consummation of the Merger (as defined
in
the Agreement and Plan of Merger, dated October 5, 2006, by and among Valentis,
Inc., Valentis Holdings, Inc. and Urigen N.A. Inc.) or the consummation of
any
other business combination or similar transaction that results in a change
of
control (as defined in the note agreement) of the Borrower, (ii) the occurrence
of an Event of Default, or (iii) the second anniversary of the date hereof
(in
each case, the “Due Date”). Also, the Company issued 500 shares of Series B
Preferred Stock, par value $0.00001 per share, in connection with this note
agreement. If this note is not paid when due, interest shall accrue
thereafter at the rate of 18% per annum.
On
June
25, 2007, the Company, upon approval of its Board of Directors, issued Benjamin
F. McGraw, III, Pharm.D., who was the Company’s Chief Executive Officer,
President and Treasurer prior to the merger, a promissory note in the amount
of
$176,000 in lieu of accrued bonus compensation owed to Dr. McGraw. The note
bears interest at the rate of 5.0% per annum, may be prepaid by the Company
in
full or in part at anytime without premium or penalty and is due and payable
in
full on December 25, 2007.
5.
|
Stockholders’
Equity
|
Reverse
Merger
On
October 5, 2006, the Company entered into an Agreement and Plan of Merger
with
Valentis, Inc., and Valentis Holdings, Inc., a newly formed wholly-owned
subsidiary of Valentis (“Merger Sub”), as subsequently amended. Pursuant to the
Merger Agreement, on July 13, 2007, Valentis Holdings was merged with and
into
the Company with the Company surviving as a wholly-owned subsidiary of
Valentis.
In connection with the Merger, each stockholder of the Company received,
in
exchange for each share of the Company’s common stock held by such stockholder
immediately prior to the closing of the Merger, 2.2554 shares of Valentis
common
stock. At the effective time of the Merger, each share of the Company’s
Series B preferred stock was exchanged for 11.277 shares of Valentis common
stock. An aggregate of 51,226,679 shares of Valentis common stock were
issued to
the Company’s stockholders.
Urigen
N.A. security holders owned,
immediately after the closing of the merger, approximately two-thirds of the
combined company on a fully-diluted basis. Further, Urigen N.A. directors
constitute a majority of the combined company’s board of directors and all
members of the executive management of the combined company are from Urigen
N.A.
Therefore, Urigen N.A. was deemed to be the acquiring company for accounting
purposes and the merger transaction will be accounted for as a reverse merger
and a recapitalization. The financial statements of the combined entity after
the merger will reflect the historical results of Urigen N.A. prior to the
merger and will not include the historical financial results of Valentis prior
to the completion of the merger. Stockholders’ equity and earnings per share of
the combined entity after the merger will be retroactively restated to reflect
the number of shares of common stock received by Urigen N.A. security holders
in
the merger, after giving effect to the difference between the par values of
the
capital stock of Urigen N.A. and Valentis, with the offset to additional paid-in
capital.
12
The
following unaudited combined condensed consolidated financial statements have
been prepared to give effect to the merger of Urigen N.A. and Valentis as a
reverse acquisition of assets and a recapitalization in accordance with
accounting principles generally accepted in the United States. For accounting
purposes, Urigen N.A. is considered to be acquiring Valentis in the merger
and
Valentis does not meet the definition of a business in accordance with Statement
of Financial Accounting Standards, SFAS No. 141, Business Combinations
(“SFAS No. 141”) , and Emerging Issue Task Force 98-3 (“EITF 98-3”),
Determining Whether a Nonmonetary Transaction Involves Receipt of Productive
Assets or of a Business , because Valentis had no material assets or liabilities
at the time of closing of the merger and these assets and liabilities do not
constitute a business pursuant to SFAS No. 141 and EITF 98-3. Consequently,
all
of the assets and liabilities of Valentis have been reflected in the financial
statements at their respective fair values and no goodwill or other intangibles
will be recorded as part of acquisition accounting and the cost of the merger
is
measured at net assets acquired.
Stock-Based
Compensation
For
the
three months ended September 30, 2007, the Company recorded $10,740 of
stock-based compensation expenses which was included in general and
administrative expense in the three months ended
September 30, 2007. There was no stock-based compensation
expense in the three months ended September 30, 2006.
The
Company did not grant any stock-based awards during the three months ended
September 30, 2007. The Company estimated the fair value of stock
options using the Black-Scholes-Merton option pricing model. The
assumptions used under this model are as follows: (i) due to insufficient
historical option exercise data, the expected term of the options was estimated
to be 6.1 years using the “simplified” method suggested in the Securities
and Exchange Commission’s Staff Accounting Bulletin No. 107; (ii) expected
volatility was estimated to be 153.7% based on the Company’s historical
volatility that matched the expected term; (iii) risk-free rate of 3.7%
is based
on the U.S. Treasury yield curve in effect at the time of grant for periods
corresponding with the expected term of the option; and (iv) the Company
assumed
a zero percent dividend yield.
Fair
value of stock awards granted is recognized as expense over the service
period,
net of estimated forfeitures. The Company estimated forfeitures based on
historical data and anticipated future conditions. The estimation of forfeitures
requires significant judgment, and to the extent actual results or updated
estimates differ from our current estimates, such amounts will be recorded
as a
cumulative adjustment in the period estimates are revised.
6.
|
Series
B Convertible Preferred Stock
Liability
|
On
July
26, 2007, the Board of Directors of Valentis, Inc. authorized the creation
of a
series of Preferred Stock of the Company to be named Series B Convertible
Preferred Stock, consisting of 210 shares, par value $0.001, 10,000,000
shares
authorized, which have the designation, powers, preferences and relative
other special rights and the qualifications, limitations and restrictions
as set
forth in the Certificate of Designation filed on July 31, 2007.
On
July
31, 2007, Urigen Pharmaceuticals, Inc. entered into a Series B Convertible
Preferred Stock Purchase Agreement (the “Purchase Agreement”) with
Platinum-Montaur Life Science, LLC (“Platinum”) for the sale of 210 shares of
its Series B Convertible Preferred Stock, par value $.001 per share,
at a
purchase price of $10,000 per share. Urigen Pharmaceuticals received
aggregate
proceeds of $1,817,000, which is net of issuance costs of $283,000.
The
Certificate of Designation, as amended and restated, setting forth the
rights
and preferences of the Series B Preferred Stock, provides for the payment
of
dividends equal to 5% per annum payable on a quarterly basis. The Company
has
the option to pay dividends in shares of common stock if the shares are
registered in an effective registration statement and the payment would
not
result in the holder exceeding any ownership limitations. The Series
B Preferred
Stock is convertible at a maximum price of $0.15 per share, subject tocertain
adjustments, other than for an increase in the conversion price in connection
with a reverse stock split by the Company.
The
Series B Preferred Stock also carries a liquidation preference of $10,000
per
share.
The
Holders of Series B Preferred stock have no voting rights except that
the
Company may not without the consent of a majority of the holders of Series
B
Preferred Stock (i) incur any indebtedness, as defined in the Purchase
Agreement, or authorize, create or issue any shares having rights superior
to
the Series B preferred stock; (ii) amend its Articles of Incorporation
or Bylaws
or in anyway alter the rights of the Series B Preferred stock, so as
to
materially and adversely affect the rights, preferences and privileges
of the
Series B Preferred Stock; (iii) repurchase, redeem or pay dividends on
any
securities of the Company that rank junior to the Series B Preferred
Stock; or
(iv) reclassify the Company's outstanding stock.
The
Company also issued to Platinum a Warrant to purchase 14,000,000 shares
of the
Company's common stock at $0.18 per share. The warrants have a term of
five
years, and expire on August 1, 2012. The warrants provide a cashless
exercise
feature; however, the holders of the warrants may make a cashless
exercise commencing twelve months after the original issue date
of August 1, 2007 only if the underlying shares are not covered by an
effective registration statement and the market value of the Company's
common
stock is greater than the warrant exercise price.
The
terms
of the Warrant provide that it may not be exercised if such exercise
would
result in the holder having beneficial ownership of more than 4.99% of
the
Company's outstanding common stock. The Amended and Restated Certificate
of
Designation contains a similar limitation and provides further that the
Series B
Preferred Stock may not be converted if such conversion, when aggregated
with
other securities held by the holder, will result in such holder's ownership
of
more than 9.99% of the Company's outstanding common stock. Beneficial
ownership
is determined in accordance with Section 13(d) of the Securities Exchange
Act of
1934, as amended, and Rule 13d-3 there under. These limitations may be
waived
upon 61 days notice to the Company.
13
In
addition to the foregoing:
·
|
The
Company agreed that for a period of 3 years after the issuance
of the
Series B Preferred Stock that in the event the Company enters
into a
financing, with terms more favorable than those attached to
the Series B
Preferred Stock, then the holders of the Series B Preferred
Stock will be
entitled to exchange their securities for shares issued in
the
financing.
|
·
|
The
Company agreed to register (i) 120% of the shares issuable
upon conversion
of the preferred shares and (ii) the shares issuable upon exercise
of the
warrants in a Registration Statement to be filed with the Securities
and
Exchange Commission (“SEC”) within 30 days of the closing and shall use
its best efforts to have the registration statement declared
effective
with 90 days, or in the event of a review by the SEC, within
120 days of
the closing. The failure of the Company to meet this schedule
and other
timetables provided in the registration rights agreement would
result in
the imposition of liquidated damages of 1.5% per month with
a maximum of
18% of the initial investment in the Series B Preferred stock
and
warrants. On September 6, 2007, Platinum extended the time to
file until September 28, 2007 without penalty. On October 3,
2007, Platinum further extended the time to file until October
15, 2007
without penalty. The Company filed a registration statement
with the SEC on October 12, 2007 and is awaiting approval by
the
SEC.
|
·
|
The
Company granted to Platinum the right to subscribe for an additional
amount of securities to maintain its proportionate ownership
interest in
any subsequent financing conducted by the Company for a period
of 3 years
from the closing date.
|
·
|
The
Company agreed to take action within 45 days to amend its bylaws
to permit
adjustments to the conversion price of the Series B Preferred
Stock and
the exercise price of the warrant. The failure of the Company
to meet this timetable will result in the imposition of liquidated
damages
of 1.5% per month until the amendment to the Bylaw is
effected. On October 3, 2007, Platinum extended the amendment
deadline to October 17, 2007, without
penalty.
|
In
December 2005, the SEC published guidance on the application of the Emerging
EITF Issue No. 00-19 “Accounting for Derivative Financial Instruments Indexed
to, and Potentially Settled in, a Company’s Own Stock” (“EITF 00-19”) in
relation to the effect of cash liquidated damages provisions upon conversion
of
convertible equity securities. Due to this interpretation of EITF 00-19, the
Company classified the $2.1 million private placement of preferred Series B
shares as a liability not equity for the period ended September 30,
2007.
The
Company determined that the liquidated damages could result in net-cash
settlement of a conversion in accordance with Emerging Issues Task Force No.
00-19, EITF 00-19 requires freestanding contracts that are settled in a
Company’s own stock to be designated as an equity instrument, assets or
liability. Under the provisions of EITF 00-19, a contract designated as an
asset
or liability must be initially recorded and carried at fair value until the
contract meets the requirements for classification as equity, until the contract
is exercised or until the contract expires.
Accordingly,
the Company determined that the Series B Preferred Stock should be accounted
for
as a liability and thus recorded the proceeds received from the issuance of
the
Series B Preferred Stock as a preferred stock liability on the consolidated
balance sheet in the amount of $2,100,000. Since the warrants issued to the
investors were not covered by the net-cash settlement provision they were also
determined to be equity in accordance with EITF 00-19. The Company valued the
warrants using the Black-Scholes model and recorded $1,127,557 as a discount
to
equity. In accordance with EITF 00-27, the Company compared the amount allocated
to the Series B Preferred Stock to the fair value of the common stock that
would
be received upon conversion to determine if a beneficial conversion feature
existed. The Company determined that a beneficial conversion feature of $972,443
existed and, in accordance with EITF 00-27, amortized that amount immediately
to
the value of the Series B Preferred Stock, as the Series B Preferred Stock
is
immediately convertible. This amount is also included in non-cash interest
expense since the Series B Preferred Stock is recorded as a
liability.
7.
|
Net
Loss Per Share
|
Basic
loss per share is computed by dividing loss applicable to common stockholders
by
the weighted-average number of shares of common stock outstanding during the
period, net of certain common shares outstanding that are held in escrow or
subject to the Company’s right of repurchase. Diluted earnings per share include
the effect of options and warrants, if dilutive. Diluted net loss per share
has
not been presented separately as, given our net loss position for all periods
presented, the result would be anti-dilutive.
A
reconciliation of shares used in the calculation of basic and diluted net loss
per share follows (in thousands, except per share amounts):
Three
months ended Sepember 30
|
||||||||
2007
|
2006
|
|||||||
Net Loss (thousands) | $ | (3,326 | ) | $ | (643 | ) | ||
Basic and Diluted (thousands): | ||||||||
Weighted
average shares of common stock outstanding
|
61,608 | 15,368 | ||||||
Weighted-average shares of common stock used in computing net loss per share (thousands) | 61,608 | 15,368 | ||||||
Basic and diluted net loss per share | $ | (0.05 | ) | $ | (0.04 | ) |
14
URIGEN
PHARMACEUTICALS, INC.
(a
development stage enterprise)
·
Warrants to purchase up to 4,724,944 shares of common stock at a weighted
average price of $3.84 per share at September 30, 2007.
·
Series B preferred shares convertible to 14,000,000 or more shares of
common stock at a price of $0.15 or less per share and Warrants to purchase
up
to 14,000,000 shares of common stock at $0.18 per share, at September 30,
2007.
The
options, common stock purchase warrants, Series B preferred
convertible shares and warrants and will be included in the
calculation of income or loss per share at such time as the effect is no longer
antidilutive, as calculated using the treasury stock method for convertible
shares and warrants.
8.
|
Related
party Transactions
|
In
January 2006, the Company entered into an agreement with Urigen, Inc., a related
party entity by stockholders in common with Urigen Holdings, Inc. As discussed
in Note 3, Urigen, Inc. transferred certain assets to Urigen Holdings, Inc.
in
exchange for the Company’s assumption of certain liabilities and subscription
agreements. As of September 30, 2007 and 2006, no amounts were due to or from
the Company.
As
of
September 30, 2007 and 2006, the Company is paying a fee of $3,487 and $1,500
per month to EGB Advisors, LLC. EGB Advisors, LLC is owned solely by
William J. Garner, M.D. and CEO of the Company. Dr. Garner owns 18,476,540
shares of common stock at September 30, 2007 and 7,762,706 shares of common
stock at September 30, 2006. The fees are for rent, telephone and other office
services which are based on estimated fair market value. Dr. Garner also
received payment for services provided as a consultant/ employee to the Company.
As of September 30, 2007 and 2006, Dr. Garner and EGB Advisors, LLC were owed
$14,610 and $40,513, respectively. For the three months ended September 30,
2007
and 2006, the Company paid $33,271 and $15,045 to this related party. From
the
inception of the Company to September 30, 2007 the Company has paid $143,382
to
this related party.
On
August
24, 2007, at the time the Company settled an outstanding balance with a vendor,
the Company also paid $15,132 on behalf of Inverseon, Inc. William J.
Garner, M.D. who is the President and CEO of Urigen is also the principle
shareholder in Inverseon, Inc. The $15,132 balance from Inverseon,
Inc. is reported as part of Other Current Assets at September 30,
2007.
9.
|
Subsequent
Events
|
On
November 2, 2007, Cynthia Sullivan was appointed as a director of the Company.
The appointment increased the size of the Company’s Board of Directors to eight
members.
The
Company received an SEC comment letter on October 26, 2007 related to the
filing
of its Form S-1. The Company was not in compliance as of November 9, 2007
with its obligations under under the Registration Rights Agreement dated
as of
August 1, 2007, entered into with Platinum-Montaur Life Sciences, LLC to
respond
to SEC comments within 14 days of our receipt of a comment letter. Failure
of
the Company to meet this schedule provided in the Registration Rights Agreement
will result in the imposition of liquidated damages of 1.5% per month with
a
maximum of 18% of the initial investment in the Series B preferred stock
and
warrants.
15
ITEM
2: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OFOPERATIONS
The
discussion in “Management’s Discussion and Analysis of Financial
Condition and Results of Operations” contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended. These
forward-looking statements include, without limitation, statements containing
the words “believes,” “anticipates,” “expects,” “intends,” “projects,” and other
words of similar import or the negative of those terms or expressions.
Forward-looking statements in this section include, but are not limited to,
expectations of future levels of research and development spending, general
and
administrative spending, levels of capital expenditures and operating results,
sufficiency of our capital resources our intention to pursue and consummate
strategic opportunities available to us, including sales of certain of our
assets and our announced potential merger with Urigen, NA, Inc. Forward-looking
statements subject to certain known and unknown risks, uncertainties and other
factors that may cause our actual results, performance or achievements to be
materially different from any future results, performance or achievements
expressed or implied by such forward-looking statements.
CORPORATE
OVERVIEW
We
were
formerly known as Valentis, Inc. and were formed as the result of the merger
of
Megabios Corp. and GeneMedicine, Inc. in March 1999. We were incorporated in
Delaware on August 12, 1997. In August 1999, we acquired U.K.-based
PolyMASC Pharmaceuticals plc.
On
October 5, 2006, we entered into an Agreement and Plan of Merger, as
subsequently amended (the “Merger”) with Urigen N.A., Inc., a Delaware
corporation (“Urigen N.A.”), and Valentis Holdings, Inc., our newly formed
wholly-owned subsidiary (“Valentis Holdings”). Pursuant to the Merger Agreement,
on July 13, 2007, Valentis Holdings was merged with and into Urigen N.A., with
Urigen N.A. surviving as our wholly-owned subsidiary. In connection with the
Merger, each Urigen stockholder received, in exchange for each share of Urigen
N.A. common stock held by such stockholder immediately prior to the closing
of
the Merger, 2.2554 shares of our common stock. At the effective time of the
Merger, each share of Urigen N.A. Series B preferred stock was exchanged
for 11.277 shares of our common stock. An aggregate of 51,226,679 shares of
our
common stock were issued to the Urigen N.A. stockholders. Upon completion of
the
Merger, we changed our name from Valentis, Inc. to Urigen Pharmaceuticals,
Inc.
Urigen
N.A. security holders owned, immediately after the closing of the merger,
approximately two-thirds of the combined company on a fully-diluted basis.
Further, Urigen N.A. directors constitute a majority of the combined company’s
board of directors and all members of the executive management of the combined
company are from Urigen N.A. Therefore, Urigen N.A. was deemed to be the
acquiring company for accounting purposes and the merger transaction will be
accounted for as a reverse merger and a recapitalization. The financial
statements of the combined entity after the merger will reflect the historical
results of Urigen N.A. prior to the merger and will not include the historical
financial results of Valentis prior to the completion of the merger.
Stockholders’ equity and earnings per share of the combined entity after the
merger will be retroactively restated to reflect the number of shares of common
stock received by Urigen N.A. security holders in the merger, after giving
effect to the difference between the par values of the capital stock of Urigen
N.A. and Valentis, with the offset to additional paid-in capital.
The
following unaudited combined condensed consolidated financial statements have
been prepared to give effect to the merger of Urigen N.A. and Valentis as a
reverse acquisition of assets and a recapitalization in accordance with
accounting principles generally accepted in the United States. For accounting
purposes, Urigen N.A. is considered to be acquiring Valentis in the merger
and
Valentis does not meet the definition of a business in accordance with Statement
of Financial Accounting Standards, SFAS No. 141, Business Combinations
(“SFAS No. 141”) , and Emerging Issue Task Force 98-3 (“EITF 98-3”),
Determining Whether a Nonmonetary Transaction Involves Receipt of Productive
Assets or of a Business , because Valentis had no material assets or liabilities
at the time of closing of the merger and these assets and liabilities do not
constitute a business pursuant to SFAS No. 141 and EITF 98-3. Consequently,
all
of the assets and liabilities of Valentis have been reflected in the financial
statements at their respective fair values and no goodwill or other intangibles
will be recorded as part of acquisition accounting and the cost of the merger
is
measured at net assets acquired.
16
From
and
after the Merger, our business is conducted through our wholly owned subsidiary
Urigen N.A. The discussion of our business in this quarterly report is that
of
our current business which is conducted through Urigen
N.A. The historical financial results discussed herein are those
of Urigen N.A. for the three months ended September 30, 2007 and
2006.
BUSINESS
OVERVIEW
The
Company specializes in the design and implementation of innovative products
for
patients with urological ailments including, specifically, the development
of
innovative products for amelioration of Painful Bladder Syndrome (PBS),
Urethritis and Overactive Bladder (OAB).
Urology
represents a specialty pharmaceutical market of approximately 12,000 physicians
in North America. Urologists treat a variety of ailments of the urinary tract
including urinary tract infections, bladder cancer, overactive bladder, urgency
and incontinence and interstitial cystitis, a subset of PBS. Many of these
indications represent significant, underserved therapeutic market
opportunities.
Over
the
next several years a number of key demographic and technological factors should
accelerate growth in the market for medical therapies to treat urological
disorders, particularly in our product categories. These factors include the
following:
·
|
Aging
population. The incidence of urological disorders increases with
age. The over-40 age group in the United States is growing
almost twice as fast as the overall population. Accordingly, the
number of
individuals developing urological disorders is expected to increase
significantly as the population ages and as life expectancies continue
to
rise.
|
·
|
Increased
consumer awareness. In recent years, the publicity associated with
new technological advances and new drug therapies has increased the
number
of patients visiting their urologists to seek treatment for urological
disorders.
|
Urigen
N.A. has been established as a specialty pharmaceutical company to develop
and
commercialize products for the treatment and diagnosis of urological disorders.
We have established an initial group of clinical stage products, as more fully
described below, that we believe offer potential solutions to underserved
urology markets.
Urigen
N.A. is a specialty pharmaceutical company dedicated to the development and
commercialization of therapeutic products for urological disorders. Our two
lead
programs target significant unmet medical needs and major market opportunities
in urology. Our URG101 project targets painful bladder syndrome which affects
approximately 10.5 million men and women in North America. URG101 has
demonstrated safety and activity in a Phase IIa (open-label) human clinical
trial and in a Phase IIb double-blind, placebo-controlled trial. URG101 is
a
unique, proprietary combination therapy of components approved by global
regulatory authorities that is locally delivered to the bladder for rapid relief
of pain and urgency. In 2007, URG101 clinical development will encompass a
pharmacodynamic study. We have also begun to develop additional indications
for URG101focusing on radiation cystitis and dyspareunia (painful
intercourse).
Our clinical-stage
projects, URG301 and URG302, target acute urgency in patients diagnosed with
an
overactive bladder, another major unmet need that is insufficiently managed
by
presently available overactive bladder drugs. URG301 and URG302are proprietary
dosage forms of approved drugs that are locally delivered to control urinary
urgency. The Company initiated development of URG301and URG302 in the
fourth quarter of 2007 and plans for a Company sponsored Investigational New
Drug Application (IND), in early 2008. We also plan to initiate two
clinical programs targeting the use of URG301 in patients diagnosed with acute
urethral discomfort, or AUD, associated with cystoscopy and
urethritis.
17
To
expand
the pipeline, we have initiated discussions with pharmaceutical companies that
have either an approved product or a product in development for the treatment
of
additional urological indications. We believe that our URG100 and URG300
programs, when commercialized, will offer significant “marketing coat-tails”
that can dramatically grow the sales of niche urology products. Although such
products do not match the potential revenue streams of URG101 and URG301, the
incremental income they could generate for us is potentially significant as
such
products will enable us to maximize the time, effort and expense of the sales
organization that we plan to establish to market URG101 and URG301 to urologists
in the United States.
We
plan
to market our products to urologists and urogynecologists in the United States
via a specialty sales force managed internally. As appropriate, our specialty
sales force will be augmented by co-promotion and licensing agreements with
pharmaceutical companies that have the infrastructure to market our products
to
general practitioners. In all other countries, we plan to license marketing
and
distribution rights to its products to pharmaceutical companies with strategic
interests in urology and gynecology.
Overview
For
the
quarter ended September 30, 2007, we incurred significant losses
primarily due to the $2,100,000 of interest expense incurred in conjunction
with
the Series B Convertible Preferred Stock and Purchase Agreement with
Platinum-Montaur Life Science LLC. We also expect that operating results
will fluctuate from quarter to quarter and that such fluctuations may be
substantial. At September 30, 2007, our accumulated deficit was
$8,118,633. We expect to incur substantial losses for the foreseeable
future and do not expect to generate revenue from the sale of products in the
foreseeable future, if at all.
There
have been no significant changes in our critical accounting policies during
the
three months ended September 30, 2007 as compared to what was
previously disclosed in our Annual Report on Form 10-K for the year ended
June 30, 2007 filed with the Securities and Exchange Commission (the
“SEC”) on October 5, 2007.
Revenue
There
were no revenues for the three months ended September 30, 2007 and
2006.
Research
and Development Expenses
Research
and development expenses decreased $257,974 to $156,081 for the three months
ended September 30, 2007. The decrease was primarily due to the
reduction in clinical trial expenses in the three months then ended. We
expect research and development expenses to increase in future quarters as
we
continue our clinical studies of our two product lines and pursue our strategic
opportunities.
General
and Administrative Expenses
General
and administrative expenses increased $781,687 to $1,000,188 for the three
months ended September 30, 2007, compared to $218,051 for the corresponding
period in 2006. The increase in general and administrative expenses was due
to
legal fees in connection with the reverse merger and the PIPE
transaction. Accounting fees increased due to the reverse merger, the
year end audits and the PIPE transaction. We expect general and
administrative expenses to decrease going forward as there will be certain
non-recurring expenses that will not repeat.
18
Sales
and Marketing Expenses
Sales
and
marketing expenses increased $38,759 to $52,564 for the three months ended
September 30, 2007, compared to $13,805 for the corresponding period in
2006. The increase is mainly due to salaries in the current period. We expect
sales and marketing expenses to increase going forward as we proceed to move
our
technologies forward towards commercialization.
Interest
Income and Other Income and Expenses, net
Interest
income and other income and expenses, net, increased by $7,787 to $11,599 for
the three months ended September 30, 2007, compared to $3,812 in the
corresponding period of 2006.
Interest
Expense
Interest
expense increase $2,128,887 to $2,128,951 for the three months ended September
30, 2007, compared to $64 in the corresponding period of 2006. The
increase was primarily due to the $2,100,000 of interest expense incurred in
conjunction with the Series B Convertible Preferred Stock and Purchase Agreement
with Platinum-Montaur Life Science LLC.
Stock-Based
Compensation
For
the
three months ended September 30, 2007, the Company recorded $10,740 of
stock-based compensation expenses which was included in general and
administrative expense in the three months ended
September 30, 2007. There was no stock-based compensation
expense in the three months ended September 30, 2006.
The
Company did not grant any stock-based awards during the three months ended
September 30, 2007. The Company estimated the fair value of stock
options using the Black-Scholes-Merton option pricing model. The assumptions
used under this model are as follows: (i) due to insufficient historical option
exercise data, the expected term of the options was estimated to be
6.1 years using the “simplified” method suggested in the Securities and
Exchange Commission’s Staff Accounting Bulletin No. 107; (ii) expected
volatility was estimated to be 153.7% based on the Company’s historical
volatility that matched the expected term; (iii) risk-free rate of 3.7% is
based
on the U.S. Treasury yield curve in effect at the time of grant for periods
corresponding with the expected term of the option; and (iv) the Company assumed
a zero percent dividend yield.
Fair
value of stock awards granted is recognized as expense over the service period,
net of estimated forfeitures. The Company estimated forfeitures based on
historical data and anticipated future conditions. The estimation of forfeitures
requires significant judgment, and to the extent actual results or updated
estimates differ from our current estimates, such amounts will be recorded
as a
cumulative adjustment in the period estimates are revised.
Liquidity
and Capital Resources
We
have
received a report from our independent registered public accounting firm
regarding the financial statements for the fiscal year ended
June 30, 2007, that includes an explanatory paragraph stating that the
financial statements have been prepared assuming the Company will continue
as a
going concern. The explanatory paragraph identifies the following conditions,
which raise substantial doubt about our ability to continue as a going concern:
(i) we have incurred operating losses since inception, including a net loss
of $4,792,448 for the fiscal year ended June 30, 2007, and a net loss
for the three months ended September 30, 2007 of $3,326,185 and an accumulated
deficit of $8,118,633 at September 30, 2007, and (ii) we anticipate to
incur further losses for the foreseeable future. The Company expects
to finance future cash needs primarily through proceeds from equity or debt
financing, loans, and/or collaborative agreements with corporate partners in
order to be able to sustain its operations.
19
Since
our
inception, we have financed our operations principally through public and
private issuances of our common and preferred stock. We have used the net
proceeds from the sale of the common and preferred stock for general corporate
purposes, which included funding development and increasing our working capital,
reducing indebtedness, pursuing and completing acquisitions of technologies
that
are complementary to our own, and capital expenditures. We expect that
proceeds received from any future issuance of stock, if any, will be used to
fund our efforts to pursue strategic opportunities.
The
accompanying consolidated financial statements have been prepared assuming
that
we will continue as a going concern.
Net
cash
used in operating activities for the three months ended
September 30, 2007 was $1,503,548, which primarily reflected the net
loss of $3,326,185, adjusted for non-cash expenses of $2,142,595. Net cash
used
in operating activities for the three months ended September 30, 2006
was $319,042, which primarily reflected the net loss of $642,613, adjusted
for
non-cash expenses of $42,072.
Net
cash
used by investing activities for the quarter ended September 30, 2007
was $926, which reflected the purchase of fixed assets. There was no net cash
used in investing activities for the quarter ended
September 30, 2006.
Net
cash
provided by financing activities for the three months ended September 30,
2007
was $2,320,099, which reflected $2,100,000 for the PIPE transactions and
$220,099 of cash received from Valentis, Inc. as part of the merger
transaction. For the three months ended September 30, 2006, net cash
provided by financing activities was $10,522, which reflected $8,271 from
the
issuance of common stock and $2,251 from the exercise of stock
options.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
Urigen’s
exposure to market risk for changes in interest rates relates primarily to
our
investment portfolio. We maintain a strict investment policy that ensures the
safety and preservation of our invested funds by limiting default risk, market
risk and reinvestment risk. Our cash and cash equivalents consist of cash and
money market accounts. The table below presents notional amounts and
related weighted-average interest rates for our investment portfolio as of
September 30, 2007 and 2006.
As
of September 30,
|
||||||||
2007
|
2006
|
|||||||
Cash
and cash equivalents
|
||||||||
Estimated
market value
|
$ |
918,745
|
$ |
261,891
|
||||
Average
interest rate
|
4.14 | % | 2.62 | % | ||||
Total
cash and cash equivalents
|
$ |
918,745
|
$ |
261,891
|
||||
Average
interest rate
|
4.14 | % | 2.62 | % |
ITEM
4. CONTROLS AND PROCEDURES
Evaluation
of Disclosure Controls and Procedures. The
Securities and Exchange Commission defines the term "disclosure controls and
procedures" to mean a company's controls and other procedures that are designed
to ensure that information required to be disclosed in the reports that it
files
or submits under the Securities Exchange Act of 1934 is recorded, processed,
summarized and reported, within the time periods specified in the Commission's
rules and forms. Our chief executive officer and chief financial officer has
concluded, based on the evaluation of the effectiveness of the disclosure
controls and procedures by our management, with the participation of our chief
executive officer and chief financial officer, as of the end of the period
covered by this report, that our disclosure controls and procedures were
effective for this purpose, except as noted below under "Changes in Internal
Controls."
Changes
in Internal Controls. In connection with its audit of our consolidated
financial statements for the year ended June 30, 2007, Burr, Pilger & Mayer
LLP identified significant deficiencies, which represent material weaknesses.
The material weaknesses were related to a lack of adequate segregation of
duties. In addition, significant audit adjustments were needed to
liabilities and stockholders’ equity and financial statement disclosure changes
were needed that were the result of an insufficient quantity of experienced
resources involved with the financial reporting and period end closing process
resulting from staff reductions associated with the downsizing of the Company.
In October 2007, the Company hired a corporate controller to begin to address
these material weaknesses.
Prior
to
the issuance of our consolidated financial statements, we completed the needed
analyses and our management review such that we can certify that the information
contained in our consolidated financial statements for the year ended June
30,
2007 and the three month periods ended September 30, 2007 and 2006,
respectively, fairly presents, in all material respects, our financial condition
and results of operations.
Limitations
on Effectiveness of Controls and Procedures. Our management,
including our chief executive officer and chief financial officer, does not
expect that our disclosure controls and procedures or our internal controls
will
prevent all errors and all fraud. A control system, no matter how well conceived
and operated, can provide only reasonable, not absolute, assurance that the
objectives of the control system are met. Further, the design of a control
system must reflect the fact that there are resource constraints and the
benefits of controls must be considered relative to their costs. Because of
the
inherent limitations in all control systems, no evaluation of controls can
provide absolute assurance that all control issues and instances of fraud,
if
any, within the Company have been detected. These inherent limitations include,
but are not limited to, the realities that judgments in decision-making can
be
faulty and that breakdowns can occur because of simple error or mistake.
Additionally, controls can be circumvented by the individual acts of some
persons, by collusion of two or more people, or by management override of the
control. The design of any system of controls also is based in part upon certain
assumptions about the likelihood of future events and there can be no assurance
that any design will succeed in achieving its stated goals under all potential
future conditions. Over time, controls may become inadequate because of changes
in conditions, or the degree of compliance with the policies or procedures
may
deteriorate. Because of the inherent limitations in a cost-effective control
system, misstatements due to error or fraud may occur and not be
detected.
20
ITEM
1. LEGAL PROCEEDINGS
None
There
are
no material changes from the risk factors previously disclosed in the
Registrant’s form 10-K filed on October 5, 2007.
None
ITEM
3. DEFAULTS UPON SENIOR SECURITIES
None
ITEM
4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
On
August 24, 2007, shareholders
holding 36,088,908 shares of the Company which represents a majority of the
Company’s common stock, voted to approve an amendment to the Company’s
Bylaws.
ITEM
5. OTHER INFORMATION
None
a.
Exhibits
3(ii)
|
Amended
Bylaws*
|
10.1
|
Employment
Agreement effective as of September 1, 2007 between Urigen
Pharmaceuticals, Inc. and Dennis Giesing (Incorporated by reference
to the
Company’s current report on Form 8-K filed on October 10,
2007)
|
31.1
|
Certification
of Principal Executive Officer pursuant to Rule 13a-14(a)/15d-14(a)
of the
Securities Exchange Act of 1934*
|
31.2
|
Certification
of Principal Financial Officer pursuant to Rule 13a-14(a)/15d-14(a)
of the
Securities Exchange Act of 1934*
|
32.1
|
Certification
of Principal Executive Officer pursuant to Rule 13a-14(b)/15d-14(b)
of the
Securities Exchange Act of 1934 and 18 U.S.C. Section
1350*
|
32.2
|
Certification
of Principal Financial Officer pursuant to Rule 13a-14(b)/15d-14(b)
of the
Securities Exchange Act of 1934 and 18 U.S.C. Section
1350*
|
*
Filed herewith
21
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.
November
14, 2007
URIGEN
PHARMACEUTICALS, INC.
|
||
|
By:
|
/s/
William J. Garner, MD
|
|
|
WILLIAM
J. GARNER, MD
|
|
|
President
and Chief Executive Officer
|
By:
|
/s/
Martin Shmagin
|
|
|
MARTIN
E. SHMAGIN
|
|
|
Chief
Financial Officer
|
22