Urigen Pharmaceuticals, Inc. - Quarter Report: 2008 March (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 March 31, 2008.
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
|
94-3156660
|
|
(State
or Other Jurisdiction of Incorporation or
Organization)
|
(IRS
Employer Identification No.)
|
|
875
Mahler Road, Suite 235, Burlingame, CA
|
94010
|
|
(Address
of Principal Executive Offices)
|
(Zip
Code)
|
(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, a non-accelerated filer, or a smaller reporting company. See
definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer o
|
Accelerated
filer o
|
Non-accelerated
filer o
|
(Do
not check if a smaller reporting company)
|
Smaller
reporting company ý
|
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 69,289,535 as of May 13, 2008.
URIGEN
PHARMACEUTICALS, INC.
(a
development stage enterprise)
INDEX
PART I: FINANCIAL
INFORMATION
|
|||||
ITEM
1:
|
3
|
||||
Condensed
Consolidated Balance Sheets
|
3
|
||||
Condensed
Consolidated Statements of Operations
|
4
|
||||
Condensed
Consolidated Statements of Cash Flows
|
5
|
||||
Notes
to the Condensed Consolidated Financial Statements
|
6
|
||||
ITEM
2:
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
|
17
|
|||
Overview
|
17
|
||||
Results
of Operations
|
19
|
||||
Liquidity
and Capital Resources
|
20
|
||||
ITEM
3 :
|
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
21
|
|||
ITEM
4:
|
CONTROLS
AND PROCEDURES
|
21
|
|||
PART II: OTHER INFORMATION
|
|||||
Item
1
|
Legal
Proceedings
|
22
|
|||
ITEM
1A :
|
RISK
FACTORS
|
22
|
|||
ITEM
2
|
UNREGISTERED
SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
|
22
|
|||
ITEM
3
|
DEFAULTS
UPON SENIOR SECURITIES
|
22
|
|||
ITEM
4
|
SUBMISSION
OF MATTERS TO A VOTE OF SECURITY HOLDERS
|
22
|
|||
ITEM
5
|
OTHER
INFORMATION
|
22
|
|||
ITEM
6:
|
EXHIBITS
|
22
|
|||
SIGNATURES
|
23
|
2
(a
development stage enterprise)
CONDENSED
CONSOLIDATED BALANCE SHEETS
(
Unaudited )
PART I: FINANCIAL
INFORMATION
ITEM
1. FINANCIAL STATEMENTS
ASSETS
|
||||||||
March
31, 2008
|
June
30, 2007
|
|||||||
Current
assets:
|
||||||||
Cash
|
$ | 136 | $ | 101,608 | ||||
Accounts
Receivable
|
21,004 | - | ||||||
Prepaid
expenses
|
285,852 | - | ||||||
Other
current assets
|
15,132 | 21,204 | ||||||
Total
current assets
|
322,124 | 122,812 | ||||||
Fixed
assets, net
|
9,809 | 4,526 | ||||||
Intangible
assets, net
|
248,688 | 259,509 | ||||||
Other
assets
|
2,300 | 1,024 | ||||||
Total
assets
|
$ | 582,921 | $ | 387,871 | ||||
LIABILITIES
AND STOCKHOLDERS' DEFICIT
|
||||||||
Current
liabilities:
|
||||||||
Account
payable
|
$ | 611,436 | $ | 693,217 | ||||
Accrued
expenses
|
1,055,267 | 385,341 | ||||||
Series
B convertible preferred stock liability
|
93,789 | - | ||||||
Series
B convertible preferred beneficial conversion feature
|
61,264 | - | ||||||
Due
to related parties
|
181,196 | 226,068 | ||||||
Notes
payable - related party
|
476,000 | 300,000 | ||||||
Total
current liabilities
|
2,478,952 | 1,604,626 | ||||||
Stockholders'
deficit:
|
||||||||
Urigen
N.A. Series B convertible preferred stock
|
- | 1,336,757 | ||||||
Series
B convertible preferred stock
|
1,087,579 | - | ||||||
Common
stock
|
69,289 | 199 | ||||||
Stock
subscribed
|
274,003 | 79,073 | ||||||
Additional
paid-in capital
|
5,553,503 | 2,139,864 | ||||||
Accumulated
other comprehensive income
|
20,120 | 19,800 | ||||||
Deficit
accumulated during the development stage
|
(8,900,525 | ) | (4,792,448 | ) | ||||
Total
stockholders' equity (deficit)
|
(1,896,031 | ) | (1,216,755 | ) | ||||
Total
liabilities and stockholders' equity (deficit)
|
$ | 582,921 | $ | 387,871 |
See accompanying notes.
3
URIGEN
PHARMACEUTICALS, INC.
(a
development stage enterprise)
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
for the
three and nine months ended March 31, 2008 and 2007 and for the period from July
18, 2005 (date of inception) to
March 31,
2008
(
Unaudited )
Cumulative
period
|
||||||||||||||
Three
Months Ended
|
Nine
Months Ended
|
from
July 18, 2005
|
||||||||||||
March
31,
|
March
31,
|
(date
of inception) to
|
||||||||||||
Operating
expenses:
|
2008
|
2007
|
2008
|
2007
|
March
31, 2008
|
|||||||||
Research
and development
|
$ |
158,173
|
$ |
95,605
|
$
|
600,350
|
$ |
682,637
|
$ |
2,162,385
|
||||
General
and administrative
|
579,579
|
499,710
|
2,269,658
|
1,138,702
|
5,083,749
|
|||||||||
Sales
and marketing
|
89,324
|
204,276
|
206,415
|
293,717
|
513,482
|
|||||||||
Total
operating expenses
|
827,076
|
799,591
|
3,076,423
|
2,115,056
|
7,759,616
|
|||||||||
Loss
from operations
|
(827,076)
|
(799,591)
|
(3,076,423)
|
(2,115,056)
|
(7,759,616)
|
|||||||||
Other
income and expense, net:
|
||||||||||||||
Interest
income
|
1,460
|
4,117
|
18,145
|
12,343
|
40,496
|
|||||||||
Interest
expense
|
(5,378)
|
(1,253)
|
(2,169,861)
|
(2,541)
|
(2,271,260)
|
|||||||||
Other
income
|
54,440
|
-
|
1,151,561
|
-
|
1,151,561
|
|||||||||
Other
expense
|
-
|
-
|
(31,500)
|
-
|
(31,500)
|
|||||||||
Exchange
gain (loss)
|
-
|
-
|
-
|
-
|
(30,206)
|
|||||||||
Total
other income and expense, net
|
50,522
|
2,864
|
(1,031,655)
|
9,802
|
(1,140,909)
|
|||||||||
Net
loss
|
$
|
(776,554)
|
$ |
(796,727)
|
$ |
(4,108,078)
|
$ |
(2,105,254)
|
$ |
(8,900,525)
|
||||
Basic
and diluted net loss per share
|
$
|
(0.01)
|
$ |
(0.01)
|
$
|
(0.06)
|
$ |
(0.03)
|
||||||
Shares
used in computing basic and diluted net loss per common share (in
thousands)
|
70,509
|
64,513
|
69,216
|
63,191
|
See
accompanying notes.
4
URIGEN
PHARMACEUTICALS, INC.
(a
development stage enterprise)
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
for the
nine months ended March 31, 2008 and 2007
and for
the period from July 18, 2005 (date of inception) to March 31, 2008
unaudited
Cumulative
|
||||||||||||
period
from
|
||||||||||||
July
18, 2005
|
||||||||||||
Nine
Months
|
Nine
Months
|
(date
of
|
||||||||||
Ended
|
Ended
|
inception)
to
|
||||||||||
March
31,
|
March
31,
|
March
31,
|
||||||||||
Cash
flows from operating activities:
|
2008
|
2007
|
2008
|
|||||||||
Net
loss
|
$ | (4,108,078 | ) | $ | (2,105,254 | ) | $ | (8,900,525 | ) | |||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Depreciation
of fixed assets
|
4,394 | 2,243 | 6,679 | |||||||||
Amortization
of intangible assets
|
10,821 | 10,821 | 29,919 | |||||||||
Stock
based compensation expensed
|
54,851 | - | 54,851 | |||||||||
Non-cash
expenses: compensation, interest, rent, and other
|
158,938 | 388,011 | 1,441,048 | |||||||||
Preferred
Series B discount and imputed interest
|
2,140,567 | - | 2,140,567 | |||||||||
Change
in fair value of Series B convertible preferred stock
liability
|
(866,120 | ) | - | (866,120 | ) | |||||||
Changes
in operating assets and liabilities, net of assets acquired in
merger:
|
||||||||||||
Other
assets
|
(85,454 | ) | (18,019 | ) | (102,682 | ) | ||||||
Accounts
payable
|
(81,781 | ) | 421,221 | 611,436 | ||||||||
Accrued
expenses
|
300,022 | 219,874 | 685,363 | |||||||||
Amounts
due to related parties
|
(44,872 | ) | (59,594 | ) | 181,196 | |||||||
Net
cash used in operating activities
|
(2,516,712 | ) | (1,140,697 | ) | (4,718,268 | ) | ||||||
Cash
flows from investing activities:
|
||||||||||||
Purchases
of fixed assets, net of assets acquired in merger
|
(5,180 | ) | (5,096 | ) | (11,961 | ) | ||||||
Asset-based
purchase, net of cash acquired, from Urigen, Inc.
|
- | - | 470,000 | |||||||||
Net
cash (used in) provided by investing activities
|
(5,180 | ) | (5,096 | ) | 458,039 | |||||||
Cash
flows from financing activities:
|
||||||||||||
Cash
acquired in consummation of reverse merger
|
220,099 | - | 220,099 | |||||||||
Proceeds
from issuance of notes payable
|
- | 300,000 | 300,000 | |||||||||
Proceeds
from stock and warrant subscription,
and
exercise of stock options
|
100,000 | 95,451 | 161,034 | |||||||||
Proceeds
from preferred stock, net of issuance costs
|
2,100,000 | 450,000 | 3,517,135 | |||||||||
Net
cash provided by financing activities
|
2,420,099 | 845,451 | 4,198,268 | |||||||||
Effect
of exchange rate changes on cash
|
321 | (2,193 | ) | 62,097 | ||||||||
Net
increase (decrease) in cash
|
(101,472 | ) | (302,535 | ) | 136 | |||||||
Cash,
beginning of period
|
101,608 | 567,489 | - | |||||||||
Cash,
end of period
|
$ | 136 | $ | 264,954 | $ | 136 |
See
accompanying notes.
5
URIGEN
PHARMACEUTICALS, INC.
(a
development stage enterprise)
NOTES
TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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 adjustments) necessary for a fair presentation of financial position
at March 31, 2008 and the results of operations for the interim
periods ended March 31, 2008 and 2007 and for the cumulative period
from July 18, 2005 (date of inception) to March 31, 2008.
The
results of operations for the three and nine months ended March 31, 2008
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 condensed 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 March
31, 2008, the Company has accumulated net losses of $8,900,525 and accumulated
negative cash flows from operations of $4,718,268 and as of March 31, 2008 has a
negative working capital of $2,156,828. 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, prepaid expenses, notes payable, accounts payable, accrued expenses, and
due to related parties approximate fair value due to their short
maturities.
Cash
Concentration
At March
31, 2008, the Company did not have bank balances at a single U.S. financial
institution in excess of the Federal Deposit Insurance Corporation coverage
limit of $100,000.
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.
8
URIGEN
PHARMACEUTICALS, INC.
(a
development stage enterprise)
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 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 as follows:
Three
Months
|
Nine
Months
|
Period
from
|
||||||||||
Ended
|
Ended
|
July
18, 2005
|
||||||||||
March
31, 2008
|
March
31, 2008
|
(date
of inception) to
|
||||||||||
March
31, 2008
|
||||||||||||
Net
loss
|
$
|
(776,554
|
)
|
$
|
(4,108,078
|
)
|
$
|
(8,900,525
|
)
|
|||
Foreign
currency translation adjustments, net of tax
|
-
|
773
|
20,120
|
|||||||||
Comprehensive
loss
|
$
|
(776,554
|
)
|
$
|
(4,107,305
|
)
|
$
|
(8,880,405
|
)
|
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.
9
URIGEN
PHARMACEUTICALS, INC.
(a
development stage enterprise)
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 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, except for the impact of FASB Staff Position (FSP) 157-2. FSP 157-2
deferred the adoption of SFAS 157 for non financial assets and liabilities until
years beginning after November 15, 2008. We are still evaluating the impact
of this standard will have on our financial position and/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 and/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).
In
December 2007, the FASB issued Statement of Financial Accounting Standards
No. 141 (revised 2007), Business Combinations (“SFAS 141(R)”).
SFAS 141(R) changes accounting for acquisitions that close beginning in
2009. More transactions and events will qualify as business combinations and
will be accounted for at fair value under the new standard. SFAS 141(R)
promotes greater use of fair values in financial reporting. Some of the changes
will introduce more volatility into earnings. SFAS 141(R) is effective for
fiscal years beginning on or after December 15, 2008. We are currently
assessing the impact that SFAS 141(R) may have on our financial position,
results of operations, and cash flows.
In
December 2007, the FASB issued Statement of Financial Accounting Standards
No. 160, Noncontrolling Interests in Financial
Statements (“SFAS 160”), an amendment of ARB No. 51. SFAS 160
will change the accounting and reporting for minority interests which will be
recharacterized as noncontrolling interests and classified as a component of
equity. SFAS 160 is effective for fiscal years beginning on or after
December 15, 2008. SFAS 160 requires retroactive adoption of the
presentation and disclosure requirements for existing minority interests. We are
currently assessing the impact that SFAS 160 may have on our financial
position, results of operations, and cash flows.
In
December 2007, the FASB issued EITF Issue 07-1 Accounting for Collaborative
Arrangements (EITF 07-1). Collaborative arrangements are agreements
between parties to participate in some type of joint operating activity. The
task force provided indicators to help identify collaborative arrangements and
provides for reporting of such arrangements on a gross or net basis pursuant to
guidance in existing authoritative literature. The task force also expanded
disclosure requirements about collaborative arrangements. Conclusions within
EITF 07-1 are to be applied retrospectively. EITF 07-1 is effective for fiscal
years beginning on or after December 15, 2008. We are currently assessing the
impact that EITF 07-1 may have on our financial position, results of operations,
and cash flows.
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 March 31, 2008, $25,000 of milestone payments have been
incurred. The Company is also required to make royalty payments of 1.5% to 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.
In
November 2007, we entered into an agreement with M & P Patent AG (Mattern)
under which we licensed worldwide rights to Mattern’s intra-nasal testosterone
product for men. The Mattern patent and intellectual property rights
were not placed in service and were not being amortized, nor included in future
amortization estimates, as of December 31, 2007. At December 31 2007, the
Company had recorded a license payment to Mattern of one million shares of
Urigen Common Stock and accrued $1,500,000 in milestone payments. The
Company terminated its license agreement with Mattern effective March 31,
2008. Accordingly, the $1,500,000 accrued liability and $1,599,750
intangible asset has been reversed and a general and administrative impairment
expense of $99,750 has been recorded, which represents the fair value of the
million shares of restricted stock that were issued. The Company
believes there will be no further payments to Mattern as a result of this
transaction.
The
summary of intangible assets acquired and related accumulated amortization as of
March 31, 2008 is as follows:
Patent
and intellectual property rights
|
$
|
278,637
|
||
Less:
Accumulated amortization
|
(29,949
|
)
|
||
Intangible
assets, net
|
$
|
248,688
|
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 $3,607 and $3,607
for the quarters ended March 31, 2008 and 2007, respectively, which is
included in research and development expense in the accompanying statements of
operations. Future estimated amortization expense is as follows:
April
1, 2008 – March 31, 2009
|
$
|
14,428
|
||
April
1, 2009 – March 31, 2010
|
14,428
|
|||
April
1, 2010 – March 31, 2011
|
14,428
|
|||
April
1, 2011 – March 31, 2012
|
14,428
|
|||
April
1, 2012 – March 31, 2013
|
14,428
|
|||
Thereafter
|
176,548
|
|||
$
|
248,688
|
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, which is being accrued as of March
31, 2008. 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
Urigen N.A. Series B Preferred Stock, par value $0.00001 per share, in
connection with this note agreement. These shares converted to common
stock at the time of the Merger.
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. Interest is being accrued as of March 31,
2008. All amounts owed by the Company to Lender hereunder are due and
payable by the Company 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 Company, (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 Urigen N.A.
Series B Preferred Stock, par value $0.00001 per share, in connection with this
note agreement. These shares converted to common stock at the time of
the Merger.
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 was due and payable in
full on December 25, 2007. On December 25, 2007, the note was
extended through June 25, 2008. Dr. McGraw is currently a member of
the Board of Directors.
5.
|
Stockholders’
Deficit
|
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 Urigen N.A.
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 was
accounted for as a reverse merger and a recapitalization. The financial
statements of the combined entity after the merger reflect the historical
results of Urigen N.A. prior to the merger and does not include the historical
financial results of Valentis prior to the completion of the merger.
Stockholders’ deficit and loss per share of the combined entity after the merger
were 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
URIGEN
PHARMACEUTICALS, INC.
(a
development stage enterprise)
The
unaudited 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, Determining Whether a Nonmonetary
Transaction Involves Receipt of Productive Assets or of a Business (“EITF
98-3”), 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 were recorded
as part of acquisition accounting and the cost of the merger was measured at net
assets acquired.
Restricted
Stock
On
January 7, 2008, the Board of Directors approved the annual restricted stock
grant for each outside director for the fiscal year ending June 30, 2008 of
46,500 shares with an exercise price based on the $0.19 closing price of the
Company’s stock on January 7, 2008.
Subscribed
Stock and Warrants
On
January 31, 2008 the Company entered into an agreement with Redington, Inc. to
provide investor relations services. Under the terms of the agreement
Redington received common stock subscribed in the amount of 380,000 shares with
an estimated fair value of $39,710. The agreement provides warrants
for Redington Inc. to purchase additional common stock at $0.15 per
share. The number of warrants to be issued is contingent upon the
increase in value of the Company’s stock from an initial closing price of $0.12
per share on January 31, 2008 with a maximum number of approximately 1 million
warrants issuable under the agreement. Vesting of these warrants is
also contingent on increase in value. If the Company raises debt or
equity exceeding $3 million by January 31, 2009 then Redington Inc. has the
option to return the 380,000 shares for $134,000.
On
February 6, 2008 the Company raised $100,000 from the sale of subscribed stock
to an independent investor, at $0.20 per share for a total of 500,000 shares,
along with 250,000 warrants at $0.25 per share exercisable until January 29,
2013.
The
Company granted 20,000 additional shares of unregistered subscribed common stock
to a vendor during the three month period ended March 31, 2008, valued at the
estimated fair value of the stock on the grant dates.
Stock-Based
Compensation
For the
three and nine months ended March 31, 2008, the Company recorded $10,740 and
$54,851, respectively, of stock-based compensation expenses which was included
in general and administrative expense. There was no stock-based
compensation expense in the nine months ended March 31, 2007.
Over the
nine months ended March 31, 2008, stock based compensation to employees
represented less than 20% of the stock based compensation total. The
balance consisted of stock compensation to vendors, recorded at the estimated
fair value of the stock.
Fair
value of stock awards granted to employees is recognized as expense over the
service period, net of estimated forfeitures. The Company estimated forfeitures
at a rate 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
|
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.
13
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 to certain
adjustments, other than for an increase in the conversion price in connection
with a reverse stock split by the Company. This conversion price of
the Series B convertible preferred stock will be adjusted upon the occurrence of
the following:
A. Effectuation
of a reverse stock split-conversion price shall be proportionally
decreased.
B. Combination
of the outstanding shares of the Company – price shall be proportionately
increased.
C. Dividend
or other distribution in shares of common stock – conversion price shall be
decreased by multiplying the conversion price by a fraction, the numerator of
which shall be the total number of common stock outstanding immediately prior to
the time of such issuance or the close of business on such record date and the
denominator of which shall be the total number of shares of Common Stock issued
and outstanding immediately prior to the time of such issuance or the close of
business on such record date plus the number of shares of Common Stock issuable
in payment of such dividend or distribution
D. Dividend
or other distribution in securities other than shares of common stock – the
number of securities the holder would have received had the holder of the Series
B preferred stock converted their shares in common stock prior to such
event.
E. If
the common stock is changed to the same or different number of shares of any
class or classes of stock, whether by reclassification, exchange, substitution
or otherwise (other than by way of a stock split or combination of shares or
stock dividends discussed above) – an appropriate revision to the conversion
price so that the holders of the series B preferred stock shall have the right
to convert into the kind and amount of securities receivable upon
reclassification, exchange, substitution or other change by holders of common
stock into which the Series B preferred stock was convertible into prior to the
trigger event.
F. If
reorganization of the Company (other than by way of a stock split or combination
of shares or stock dividends or distributions or reclassification, exchange or
substitution of shares discussed above), or merger or consolidation with or into
another company, or the sale of all or substantially all of the company’s
properties or assets to any other person – appropriate revision in the
conversion price so that the holders will have the right to convert the series B
preferred stock into the kind and amount of stock and other securities or
property of the Company or any successor corporation as the holder would have
received if the holder had converted into common stock prior to trigger
event.
G. If
the company issues or sell any additional shares of common stock (other than
provided above or the exercise or conversion of convertible securities issued
prior to the Series B preferred stock) at a price less than the conversion price
– conversion price shall be reset to the price at which such additional shares
are issued or sold.
H. If
the Company issues any securities convertible into or exchangeable for common
stock or any rights or warrants or options to purchase such common stock or
convertible securities (“Common Stock Equivalents”), other than the series B
preferred stock or warrants issued to the holders, and the aggregate of the
price per share for which additional shares of common may be issued thereafter
pursuant to such common stock equivalent plus the consideration received by the
company for issuance of such common stock equivalent divided by the number of
shares issuable pursuant to such Common Stock Equivalent ( “Aggregate Per Common
Share price”) shall be less than the conversion price-the conversion price shall
be adjusted to the Aggregate Per Common Share Price.
No
adjustment in the conversion price shall be made in the event of the following
issuances:
(i) shares
of common stock or options to employees, officers or directors of the Company
pursuant to any stock or option plan;
(ii) securities
upon the exercise or exchange of or conversion of any securities issued pursuant
to the Certificate of Designation and/or securities exercisable or exchangeable
for or convertible into shares of Common Stock issued and outstanding on the
date of issuance of the series B preferred stock, provided that such securities
have not been subsequently amended to increase the number of such securities or
to decrease the exercise, exchange or conversion price of any such
securities;
(iii) securities
issued pursuant to acquisitions or strategic transactions (including license
agreements), provided any such issuance shall only be to a Person which is,
itself or through its subsidiaries, an operating company in a business
synergistic with the business of the Company and in which the Company receives
benefits in addition to the investment of funds, but shall not include a
transaction in which the Company is issuing securities primarily for the purpose
of raising capital or to an entity whose primary business is investing in
securities;
(iv) securities
issued to Platinum pursuant to the Purchase Agreement.
As of
March 31 2008, there are no adjustments to the Series B Preferred conversion
price which remains $0.15 per share.
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. On December 13,
2007, registration by the Company of 13,120,000 of the underlying shares became
effective.
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.
14
URIGEN
PHARMACEUTICALS, INC.
(a
development stage enterprise)
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.
|
·
|
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 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 receipt of
a comment letter. Failure of the Company to meet this schedule provided in
the Registration Rights Agreement resulted in the imposition of liquidated
damages of $31,500, which was paid in
cash.
|
·
|
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. The bylaw
amendment became effective October 16,
2007.
|
In
December 2005, the SEC published guidance on the application of the 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 Series B Preferred Stock 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,
at September 30, 2007, 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 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 and the relative fair value amount allocated to the
warrants immediately, as the Series B Preferred Stock is immediately
convertible. This amount was also included in non-cash interest
expense.
During
the three month period ended December 31, 2007, based on changes in market value
of the underlying shares, and based on registration of 13,120,000 of the
underlying shares becoming effective on December 13, 2007, the Company, in
accordance with EITF 00-19, recognized the change in fair value as other income
in the amount of $894,316 and reclassified $1,087,579 of liability related to
Series B Preferred Stock to equity. In addition, the Company
reclassified $911,179 of Series B preferred stock beneficial conversion feature
liability to additional paid-in capital based on the proportion of shares
registered and declared effective by the SEC on December 13,
2007. During the three month period ended March 31, 2008, based on
changes in market value of the remaining unregistered shares classified as debt,
the Company, in accordance with EITF 00-19, recognized the change in fair value
as other income in the amount of $24,316.
7.
|
Net
Loss Per Share
|
Basic net
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 net loss per share
includes the effect of convertible securities, 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.
On July
13, 2007, the Company acquired all of the outstanding stock of Urigen
N.A. For accounting purposes the acquisition has been treated as a
recapitalization of Urigen N.A. with Urigen N.A. as the acquirer (reverse
acquisition). The historical financial statements prior to July 13,
2007, are those of Urigen N.A. For net loss per share calculations
the shares issued in the reverse merger acquisition have been reflected as if
the acquisition took place on July 1, 2006.
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
|
Nine Months Ended
|
||||||||||||||||
March 31,
|
March 31,
|
||||||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||||||
Net
loss (thousands)
|
$ | (777 | ) | $ | (797 | ) | $ |
(2,105
|
) | ||||||||
63,191
|
|||||||||||||||||
Basic
and Diluted (thousands):
|
70,509 | 64,513 | $ | (4,108 | ) | $ | |||||||||||
Weighted
average shares of common stock outstanding
|
70,509 | 64,513 | 69,216 | 63,191 | |||||||||||||
Weighted-average
shares of common stock used in computing net loss per
share
|
69,216 | ||||||||||||||||
Basic and diluted net loss per share | $ | (0.01 | ) | $ | (0.01 | ) | $ | (0.06 | ) | $ | (0.03 | ) |
15
URIGEN
PHARMACEUTICALS, INC.
(a
development stage enterprise)
The
following options, common stock purchase warrants, Series B Preferred Stock
and warrants 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.
· Warrants to
purchase up to 5 million shares of common stock at a weighted average price of
$3.65 per share, outstanding at March 31, 2008.
· Series B
Preferred Stock 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, outstanding at
March 31, 2008.
· Options
to purchase approximately 1.4 million shares of common stock at an average price
of $11.62 per share, outstanding at March 31, 2008.
8.
|
Related
party Transactions
|
As of
March 31, 2008 and 2007, the Company has been paying a fee of approximately
$3,500 per month to EGB Advisors, LLC. EGB Advisors, LLC is owned solely by
William J. Garner, M.D., President and CEO of the Company. Dr. Garner owned
18,476,540 shares of common stock at March 31, 2008 and 7,870,556 shares of
common stock at March 31, 2007. The fees are for rent, telephone and other
office services, and are based on estimated fair value. Dr. Garner personally
guarantees the payment of rent. Dr. Garner has also received payment
for services provided as an employee to the Company, and in 2006, as a
consultant to the Company. Dr. Garner and EGB Advisors, LLC were owed
a total of $29,967 as of March 31, 2008 and $23,685, as of March 31, 2007. For
the three months ended March 31, 2008 and 2007, the Company paid $33,697 and
$27,299 to this related party. From the inception of the Company to March 31,
2008 the Company has paid $299,021 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 principal
shareholder in Inverseon, Inc. The $15,132 balance due from
Inverseon, Inc. is reported as part of other current assets at March 31,
2008.
On March
19, 2008, the Company entered into a consulting agreement with Benjamin F.
McGraw, III, Pharm.D., who is a member of the board of
directors. Under the terms of the agreement, Dr. McGraw is to provide
consulting services to the Company at a rate of $3,600 per month payable in cash
or in stock at the market value on the date of the invoice. No
expense has been incurred under this agreement as of March 31,
2008.
9.
|
Subsequent
Events
|
On April
25, 2008, the Company informed M & P Patent that it intends to file a demand
for arbitration against M & P Patent AG with the International Chamber of
Commerce pursuant to the terms of the Development and License Agreement entered
into on November 22, 2007. Pursuant to various provisions of the Swiss Code of
Obligations, the Company intends to seek return of the one million (1,000,000)
restricted common shares of the Company issued to M & P under the terms of
the Development and License Agreement and relief from any and all payment
obligations, if any, under the Development and License Agreement.
Subsequent
to March 31, 2008 the Company raised $75,000 from sale of subscribed stock to C.
Lowell Parsons M.D., a member of the board of directors, and $118,000 from the
sale of subscribed stock to independent investors for a total cash proceeds of
$193,000. The company also granted subscribed stock to principals of
Life Science Strategy Group, LLC in exchange for forgiveness of $25,000 in
debt.
These
subscriptions involved a total of 1,282,353 shares subscribed, all at $0.17 per
share, along with 567,647 warrants subscribed. These warrants have an
exercise price of $0.22 per share and are exercisable over a five year
period.
16
ITEM
2: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
This
report 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,” “will,” 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. 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. These risks
and uncertainties include, but are not limited to, those described in Part I,
“Item 1A. Risk Factors” of 10-K reports filed with the Securities and Exchange
Commission and those described from time to time in our future reports filed
with the Securities and Exchange Commission.
CORPORATE
OVERVIEW
We are a
specialty pharmaceutical company dedicated to the development and
commercialization of therapeutic products for urological disorders. Urigen's
product candidates target significant acute unmet medical needs and major market
opportunities in urology:
·
|
URG101
(lidocaine, heparin) a bladder instillation for Painful Bladder Syndrome /
Interstitial Cystitis is our most advanced product. An interim analysis of
URG101-104 Phase II study was successfully completed. The
results demonstrated URG101 was statistically superior to placebo in
reducing symptoms of PBS/IC. Due to the positive clinical
results the clinical study was closed early at approximately 50%
enrollment. Plans are underway to advance the project into late
stage clinical development. Additionally, the US Patent office has
notified our licensor regarding allowance of claims covering the URG101
product. Finally, Heparin which is a component of URG101 experienced
supply disruption due to contaminated raw material originating in
China. Both the United States Food and Drug Administration and
Baxter, which supplies the heparin used in URG101 are vigorously pursuing
resolution of the issue. Due to the medical importance of
heparin it is expected resolution of the contamination issue will occur in
a reasonable time frame.
|
·
|
URG301
(lidocaine) urethral suppository for Urethritis and Nocturia in women is
our second product candidate. URG301 contains lidocaine in a meltable
matrix and a placebo clinical trial is planned for 2008 for design and
tolerability.
|
·
|
We
have returned the worldwide rights to a nasal testosterone product
candidate for male hypogonadism, Nasobal, – that we designated URG201, to
the licensor, Mattern Pharmaceuticals, AG of
Switzerland.
|
We
currently have no products approved for commercial sale and have not generated
operating revenues. We currently maintain the commercial rights to our product
candidates in both the United States and in territories outside 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 our products to pharmaceutical companies with strategic
interests in urology and gynecology.
17
We expect
to expend substantial amounts of money for the development of our products. In
particular, we are continuing to expend substantial funds for URG101 and other
development programs.
There can
be no assurance that results of any ongoing or future pre-clinical or clinical
trials will be successful, that additional trials will not be required, that any
drug or product under development will receive FDA approval in a timely manner
or at all, or that such drug or product could be successfully manufactured in
accordance with U.S. current Good Manufacturing Practices, or successfully
marketed in a timely manner, or at all, or that we will have sufficient funds to
develop or commercialize any of our products.
Estimating
costs and time to complete development of our programs is difficult due to the
uncertainties of the development process and the requirements of the FDA which
could necessitate additional and unexpected clinical trials or other
development, testing and analysis. Results of any testing could result in a
decision to alter or terminate development of a compound, in which case
estimated future costs could change substantially. In the event we were to enter
into a licensing or other collaborative agreement with a corporate partner
involving sharing, funding or assumption by such corporate partner of
development costs, the estimated development costs to be incurred by us could be
substantially less than the estimates below. Additionally, research and
development costs are extremely difficult to estimate for alternate routes of
delivery of compounds due to the fact that there is generally less comprehensive
data available to determine the development activities that would be required
prior to the filing of an NDA. Given these uncertainties and other risks,
variables and considerations related to each compound and regulatory
uncertainties in general, we estimate remaining budgetary research and
development costs, excluding allocation of corporate general and administrative
expenses, from April 1, 2008 through the preparation of an NDA for our major
programs currently being developed as follows: approximately $14,500,000 for
URG101 for painful bladder syndrome and approximately $26,400,000 for URG301.
Actual costs to complete any of our products may differ significantly from the
estimates. We cannot reasonably estimate the date of completion for any compound
that is not at least in Phase III clinical development due to uncertainty of the
number, size, and duration of the trials which may be required to complete
development.
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 N.A. 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 was
accounted for as a reverse merger and a recapitalization. The financial
statements of the combined entity after the merger reflect the historical
results of Urigen N.A. prior to the merger and do not include the historical
financial results of Valentis prior to the completion of the merger.
Stockholders’ deficit and loss per share of the combined entity after the merger
were 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
unaudited 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. was
considered to be acquiring Valentis in the merger and Valentis did 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, Determining Whether a Nonmonetary
Transaction Involves Receipt of Productive Assets or of a Business (“EITF
98-3”), 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 were recorded
as part of acquisition accounting and the cost of the merger was measured at net
assets acquired. 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 and nine months ended
March 31, 2007.
18
Overview
For the
quarter ended March 31, 2008, we recorded other non-cash income due to
market changes in the valuation of Series B Convertible Preferred Stock
classified as debt, as well as other cash income from a state tax
refund.
We expect
that operating results will fluctuate from quarter to quarter and that such
fluctuations may be substantial. At March 31, 2008, our accumulated deficit was
$8,900,525. 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
nine months ended March 31, 2008 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 operating revenues for the three and nine month periods ended March 31,
2008 and 2007.
Research
and Development Expenses
Research
and development expenses increased $62,568 to $158,173 for the three months
ended March 31, 2008 compared to $95,605 for the corresponding period
in 2007. The increase was primarily due to expenses for the interim
analysis of the URG101-104 Phase II study in the three months then
ended.
Research
and development expenses decreased $82,287 to $600,350 for the nine months ended
March 31, 2008 compared to $682,637 for the corresponding period in
2007. The decrease was primarily due to decreased clinical trial
expenses overall in the nine 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 by $79,869 to $579,579 for the three
months ended March 31, 2008, compared to $499,710 for the corresponding period
in 2007.
General
and administrative expenses increased by $1,130,956 to $2,269,658 for the nine
months ended March 31, 2008, compared to $1,138,702 for the corresponding period
in 2007.
These
increases were due to increasing legal and accounting fees in connection with
the reverse merger, convertible preferred stock transaction, and public company
operating expenses. We expect general and administrative expenses to
increase going forward, in the long term, as we proceed to move our technologies
forward toward commercialization.
19
Sales
and Marketing Expenses
Sales and
marketing expenses decreased $114,952 to $89,324 for the three months ended
March 31, 2008, compared to $204,276 for the corresponding period in 2007. The
decrease is mainly due to decreased salaries in the current period.
Sales and
marketing expenses decreased $87,302 to $206,415 for the nine months ended March
31, 2008, compared to $293,717 for the corresponding period in 2007. The
decrease is mainly due to decreased salaries and marketing
activities.
We expect
sales and marketing expenses to increase going forward as we proceed to move our
technologies forward toward commercialization.
Interest
Income and Other Income and Expenses, net
Interest
income decreased by $2,657 to $1,460 for the three months ended March 31, 2008,
compared to $4,117 in the corresponding period of 2007. Interest income
increased by $5,802 to $18,145 for the nine months ended March 31, 2008,
compared to $12,343 in the corresponding period of
2007. The changes are non-cash income due to market changes in
the valuation of Series B Convertible Preferred Stock which is classified as
debt and therefore being marked to market each period.
Other
income increased to $54,440 and $1,151,561, respectively for the three and nine
month periods ended March 31, 2008, compared to $0 in the corresponding periods
of 2007. The increase is due primarily to the effective registration
of Series B Preferred Stock which is classified as debt, and to the
collection of $200,000 in other income related to technology
licensing. This income is not expected to reoccur.
Other
expense increased to $31,500 for the nine months ended March 31, 2008, compared
to $0 in the corresponding periods of 2007. The increase is due to
liquidated damages paid associated with Series B Preferred
Stock. This expense is not expected to reoccur.
Interest
Expense
Interest
expense increased by $4,125 to $5,378 for the three months ended March 31, 2008,
compared to $1,253 in the corresponding period of 2007. The
increase is mainly due to increased borrowing. We expect interest expense
to increase going forward, in the long term, as we proceed to move our
technologies forward toward commercialization.
Interest
expense increased by $2,167,320 to $2,169,861 for the nine months ended
March 31, 2008, compared to $2,541 in the corresponding period of
2007. The increase is mainly due to accrued non-cash interest expense
associated with Series B Preferred Stock. Interest expense and is expected to
decrease going forward.
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 nine months ended March 31, 2008 of $4,108,078 and an accumulated
deficit of $8,900,525 at March 31, 2008, 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.
20
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 condensed consolidated financial statements have been prepared
assuming that we will continue as a going concern.
Net cash
used in operating activities for the nine months ended March 31, 2008
was $2,516,468, which primarily reflected the net loss of $4,108,078 adjusted
for non-cash expenses of 2,354,356 and change in fair value of liability of
$866,120 and change in accrued expenses of $300,022. Net cash used in operating
activities for the nine months ended March 31, 2007 was $1,140,697,
which primarily reflected the net loss of $2,105,254, adjusted for non-cash
expenses of $388,011, changes in accounts payable of $421,221, and for changes
in accrued expenses of $219,874.
Net cash
used by investing activities for the nine month periods ended
March 31, 2008 and 2007 was $5,180 and $5,096, respectively, which
reflected the purchase of fixed assets.
Net cash
provided by financing activities for the nine months ended March 31, 2008 was
$2,420,099, which reflected $2,100,000 for the preferred stock issuance
transaction and $220,099 of cash received from Valentis, Inc. as part of the
merger transaction, and $100,000 of cash from stock and warrant
subscriptions. For the nine months ended March 31, 2007, net cash
provided by financing activities was $845,451, which was primarily $300,000 from
the issuance of notes payable and $450,000 from the issuance of Urigen N.A.
Series B preferred stock.
The
Company had a working capital deficit of $2,156,828 at March 31,
2008.
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 consists of cash and money market
accounts. The table below presents notional amounts and related
weighted-average interest rates for our investment portfolio as of
March 31, 2008.
March
31, 2008
|
||||
Cash
|
||||
Estimated
market value
|
$
|
136
|
||
Average
interest rate
|
3.02%
|
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 have 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 not effective for this purpose, due to
the material weaknesses 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, our independent registered accounting firm 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. As of this filing, the Company has revised
it’s code of business conduct and ethics, which is attached as exhibit (14.01)
to this filing and which is also accessible on the Company’s
website.
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 and nine month periods ended March 31, 2008 and 2007,
respectively, fairly present, 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.
21
ITEM
1. LEGAL PROCEEDINGS
None.
There are
no material changes from the risk factors previously disclosed in our Form 10-K
for the year ended June 30, 2007 filed with the SEC on October 5,
2007.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
In
January 2008, the Company issued to Redington, Inc. common stock subscribed in
the amount of 380,000 shares with an estimated fair value of
$39,710.
In
February 2008, the Company issued to an independent investor 500,000 shares of
common stock subscribed along with 250,000 of warrants subscribed. These
shares were valued at $0.20 per share for an aggregate of
$100,000. These warrants have an exercise price of $0.25 per share
and are exercisable over a five year period.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM
4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None.
ITEM
5. OTHER INFORMATION
None.
ITEM 6. EXHIBITS
a.
Exhibits
14.01
|
Urigen
Pharmaceuticals Inc. Code of Business Conduct and Ethics, effective May
15, 2008
|
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
22
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.
URIGEN
PHARMACEUTICALS, INC.
|
||
By:
|
/s/
William J. Garner, MD
|
|
May 15, 2008 |
WILLIAM
J. GARNER, MD
|
|
President
and Chief Executive Officer
|
||
By:
|
/s/
Martin E. Shmagin
|
|
MARTIN
E. SHMAGIN
|
||
Chief
Financial Officer
|
23