Urigen Pharmaceuticals, Inc. - Quarter Report: 2009 December (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 December 31, 2009.
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
Urigen
Pharmaceuticals, Inc.
(Exact
Name of Registrant as Specified in Its Charter)
Delaware
|
94-3156660
|
|
(State
or Other Jurisdiction of Incorporation or
Organization)
|
(IRS
Employer Identification No.)
|
|
27
Maiden Lane, San Francisco, CA
|
94108
|
|
(Address
of Principal Executive Offices)
|
(Zip
Code)
|
(415) 781-0350
(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. ý
Yes
o No
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).
o
Yes ý No
The
number of outstanding shares of the registrant’s Common Stock, $0.001 par value,
was 76,244,327 as of February 12, 2010.
1
URIGEN
PHARMACEUTICALS, INC.
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 Unaudited Condensed Consolidated Financial
Statements
|
6
|
||
ITEM
2:
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
|
21
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|
Overview
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21
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||
Results
of Operations
|
29
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||
Liquidity
and Capital Resources
|
30
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||
ITEM
3 :
|
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
31
|
|
ITEM
4:
|
CONTROLS
AND PROCEDURES
|
31
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|
PART
II: OTHER INFORMATION
|
32
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||
ITEM
1:
|
LEGAL
PROCEEDINGS
|
32
|
|
ITEM
1A:
|
RISK
FACTORS
|
32
|
|
ITEM
2:
|
UNREGISTERED
SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
|
32
|
|
ITEM
3:
|
DEFAULTS
UPON SENIOR SECURITIES
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32
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|
ITEM
4:
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SUBMISSION
OF MATTERS TO A VOTE OF SECURITY HOLDERS
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32
|
|
ITEM
5:
|
OTHER
INFORMATION
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32
|
|
ITEM
6:
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EXHIBITS
|
33
|
|
SIGNATURES
|
34
|
2
ITEM
1. FINANCIAL STATEMENTS
URIGEN
PHARMACEUTICALS, INC.
(a
development stage company)
CONDENSED
CONSOLIDATED BALANCE SHEETS
(Unaudited)
ASSETS
|
||||||||
December
31, 2009
|
June
30, 2009
|
|||||||
Current
assets:
|
||||||||
Cash
|
$ | 401 | $ | 2,805 | ||||
Prepaid
expenses and other assets
|
75,722 | 34,276 | ||||||
Total
current assets
|
76,123 | 37,081 | ||||||
Due
from related party
|
16,544 | 16,691 | ||||||
Property
and equipment, net
|
1,074 | 2,299 | ||||||
Intangible
assets, net
|
223,439 | 230,653 | ||||||
Other
assets
|
58,584 | 72,500 | ||||||
Total
assets
|
$ | 375,764 | $ | 359,224 | ||||
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
||||||||
Current
liabilities:
|
||||||||
Account
payable
|
$ | 633,006 | $ | 595,902 | ||||
Accrued
expenses
|
2,562,796 | 2,306,130 | ||||||
Series
B convertible preferred stock liability
|
788,000 | 709,200 | ||||||
Series
B convertible preferred beneficial conversion feature
|
75,264 | 75,264 | ||||||
Series
B dividends payable
|
179,164 | 142,861 | ||||||
Warrants
liability
|
1,395,038 | - | ||||||
Notes
Payable
|
246,000 | 145,000 | ||||||
Due
to related parties
|
97,900 | 257,218 | ||||||
Notes
payable - related parties
|
585,114 | 886,125 | ||||||
Total
current liabilities
|
6,562,282 | 5,117,700 | ||||||
Commitments
and contingencies (Note 3)
|
||||||||
Stockholders'
equity (deficit):
|
||||||||
Series
B convertible preferred stock
|
1,087,579 | 1,087,579 | ||||||
Common
stock
|
73,745 | 73,495 | ||||||
Subscribed
stock
|
859,090 | 79,961 | ||||||
Additional
paid-in capital
|
4,729,260 | 5,873,882 | ||||||
Accumulated
other comprehensive income
|
20,120 | 20,120 | ||||||
Deficit
accumulated during the development stage
|
(12,956,312 | ) | (11,893,513 | ) | ||||
Total
stockholders' deficit
|
(6,186,518 | ) | (4,758,476 | ) | ||||
Total
liabilities and stockholders' deficit
|
$ | 375,764 | $ | 359,224 | ||||
See
accompanying notes to financial statements
3
URIGEN
PHARMACEUTICALS, INC.
(a
development stage company)
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Cumulative
period
|
||||||||||||||||||||
from
July 18, 2005
|
||||||||||||||||||||
Three
Months Ended December 31,
|
Six
Months Ended December 31,
|
(date
of inception) to
|
||||||||||||||||||
2009
|
2008
|
2009
|
2008
|
December
31, 2009
|
||||||||||||||||
Operating
expenses:
|
||||||||||||||||||||
Research
and development
|
$ | 3,532 | $ | 59,099 | $ | 10,982 | $ | 153,802 | $ | 2,452,460 | ||||||||||
General
and administrative
|
239,111 | 357,044 | 586,881 | 742,318 | 7,695,128 | |||||||||||||||
Sales
and marketing
|
- | 38,197 | - | 88,680 | 648,346 | |||||||||||||||
Total
operating expenses
|
242,643 | 454,340 | 597,863 | 984,800 | 10,795,934 | |||||||||||||||
Loss
from operations
|
(242,643 | ) | (454,340 | ) | (597,863 | ) | (984,800 | ) | (10,795,934 | ) | ||||||||||
Other
income (expense), net:
|
||||||||||||||||||||
Interest
income
|
424 | 455 | 853 | 656 | 43,134 | |||||||||||||||
Interest
expense
|
(64,256 | ) | (30,985 | ) | (136,048 | ) | (69,155 | ) | (2,662,625 | ) | ||||||||||
Other
income (expense), net
|
(701,489 | ) | 53,898 | (223,424 | ) | 160,331 | 565,430 | |||||||||||||
Total
other income (expense), net
|
(765,321 | ) | 23,368 | (358,619 | ) | 91,832 | (2,054,061 | ) | ||||||||||||
Net
loss
|
(1,007,964 | ) | (430,972 | ) | (956,482 | ) | (892,968 | ) | (12,849,995 | ) | ||||||||||
Deemed
dividend related to incremental
|
||||||||||||||||||||
beneficial
conversion feature on preferred stock
|
- | - | - | - | 188,000 | |||||||||||||||
Accretion
of dividend on preferred stock
|
18,265 | - | 36,304 | - | 123,532 | |||||||||||||||
Net
loss attributable to common stockholders
|
$ | (1,026,229 | ) | $ | (430,972 | ) | $ | (992,786 | ) | $ | (892,968 | ) | $ | (13,161,527 | ) | |||||
Basic
and diluted net loss per share
|
$ | (0.01 | ) | $ | (0.01 | ) | $ | (0.01 | ) | $ | (0.01 | ) | ||||||||
Shares
used in computing basic and diluted net loss per share (in
thousands)
|
79,887 | 72,214 | 77,007 | 72,108 | ||||||||||||||||
|
See
accompanying notes to financial statements
4
URIGEN
PHARMACEUTICALS, INC.
(a
development stage company)
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Cumulative
period
|
||||||||||||
from
July 18, 2005
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||||||||||||
Six
Months Ended December 31,
|
(date
of inception) to
|
|||||||||||
2009
|
2008
|
December
31, 2009
|
||||||||||
Cash
flows from operating activities:
|
||||||||||||
Net
loss
|
$ | (956,482 | ) | $ | (892,968 | ) | $ | (12,849,995 | ) | |||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Depreciation
|
1,225 | 3,490 | 13,395 | |||||||||
Amortization
of intangible assets
|
7,214 | 7,214 | 55,198 | |||||||||
Non-cash
expenses: compensation, interest, rent, and other
|
65,978 | 8,729 | 1,822,776 | |||||||||
Preferred
Series B discount and imputed interest
|
- | - | 2,156,270 | |||||||||
Change
in fair value of Series B convertible preferred stock
liability
|
78,800 | (40,526 | ) | (504,421 | ) | |||||||
Change
in fair value of warrants liability
|
137,363 | - | 137,363 | |||||||||
Changes
in operating assets and liabilities:
|
||||||||||||
Prepaid
expenses and other assets
|
(27,530 | ) | (13,608 | ) | 87,300 | |||||||
Due
from related party
|
147 | (651 | ) | (16,544 | ) | |||||||
Accounts
payable
|
65,548 | 54,972 | 661,451 | |||||||||
Accrued
expenses
|
269,593 | 562,472 | 2,367,008 | |||||||||
Due
to related parties
|
30,240 | 59,581 | 287,458 | |||||||||
Net
cash used in operating activities
|
(327,904 | ) | (251,295 | ) | (5,782,741 | ) | ||||||
Cash
flows from investing activities:
|
||||||||||||
Purchases
of property and equipment
|
- | - | (11,306 | ) | ||||||||
Proceeds
from sale of property and equipment
|
- | 1,331 | 1,331 | |||||||||
Asset-based
purchase, net of cash acquired, from Urigen, Inc.
|
- | - | 470,000 | |||||||||
Net
cash provided by investing activities
|
- | 1,331 | 460,025 | |||||||||
Cash
flows from financing activities:
|
||||||||||||
Cash
acquired in consummation of reverse merger, net
|
- | - | 222,351 | |||||||||
Proceeds
from issuance of notes payable
|
- | 20,000 | 20,000 | |||||||||
Proceeds
from issuance of notes payable - related parties
|
290,500 | 185,000 | 1,087,500 | |||||||||
Payment
of receivables from stockholders
|
- | - | 45,724 | |||||||||
Proceeds
from stock and warrant subscriptions, and exercise of stock
options
|
35,000 | - | 368,310 | |||||||||
Proceeds
from issuance of Urigen N.A. Series B convertible preferred
stock,
|
||||||||||||
net
of issuance costs
|
- | - | 415,000 | |||||||||
Proceeds
from issuance of Urigen N.A. Series A preferred stock,
|
||||||||||||
net
of issuance costs
|
- | - | 1,002,135 | |||||||||
Proceeds
from issuance of Series B convertible preferred stock
|
- | - | 2,100,000 | |||||||||
Net
cash provided by financing activities
|
325,500 | 205,000 | 5,261,020 | |||||||||
Effect
of exchange rate changes on cash
|
- | - | 62,097 | |||||||||
Net
increase (decrease) in cash
|
(2,404 | ) | (44,964 | ) | 401 | |||||||
Cash,
beginning of period
|
2,805 | 45,509 | - | |||||||||
Cash,
end of period
|
$ | 401 | $ | 545 | $ | 401 | ||||||
|
See
accompanying notes to financial statements
5
URIGEN
PHARMACEUTICALS, INC.
(a
development stage company)
NOTES
TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
1.
|
Organization
|
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 accounting principles generally accepted
in the United States of America (GAAP) and 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. Accordingly, 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 December 31, 2009 and the results of operations for the interim
periods ended December 31, 2009 and 2008 and for the cumulative period from
July 18, 2005 (date of inception) to December 31, 2009. The condensed
consolidated balance sheet data as of June 30, 2009 was derived from audited
financial statements, but does not include all disclosures
required.
The
results of operations for the six months ended December 31, 2009 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, 2010. These interim condensed consolidated financial
statements should be read in conjunction with the audited consolidated financial
statements for the fiscal year ended June 30, 2009, which are
contained in Urigen’s Annual Report on Form 10-K filed with the Securities
and Exchange Commission.
2.
|
Significant
Accounting Policies
|
Basis
of Presentation/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
December 31, 2009, the Company has accumulated net losses of $12,849,995 and
negative cash flows from operations of $5,782,741 and as of December 31, 2009
the Company has a negative working capital of $6,486,159. 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 financing,
licensing agreements, 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, especially in light of current economic conditions
and a resultant credit freeze. These matters raise substantial doubt about the
Company’s ability to continue as a going concern. The accompanying
condensed consolidated financial statements do not include any adjustments that
might result from the outcome of this uncertainty.
The
Company has had recurring operating losses and has been unable to obtain
financing to fully fund its operations. As such, the Company continues to
explore alternatives, including strategic transactions, or licensing
of intellectual property. Pending the outcome of the Company’s
review of its alternatives, the Company will continue to prepare its financial
statements on the assumption that it will continue as a going concern, which
contemplates the realization of assets and liquidation of liabilities in the
normal course of business. As such, the financial statements do not include any
adjustments to reflect possible future effects on the recoverability and
classification of assets or the amounts and classification of liabilities that
may result from any decisions made with respect to the Company’s assessment of
its strategic alternatives. If at some point the Company were to decide to
pursue alternative plans, the Company may be required to present the financial
statements on a different basis.
Principles
of Consolidation
The
condensed consolidated financial statements include the accounts of Urigen
Pharmaceuticals, Inc. and its wholly-owned subsidiary Urigen N.A. All
significant intercompany balances and transactions have been
eliminated.
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.
6
Fair
Value of Financial Instruments
The
carrying amounts of certain of the Company’s financial instruments including
cash, note receivable from related party, prepaid expenses, notes payable,
accounts payable, accrued expenses, and due to related parties approximate fair
value due to their short maturities.
Company
policy is to value its stock based on the average of the daily open and close
price except where accounting standards or contractual terms specifically call
for a different method. Based on restricted stock valuation studies
the Company assumes a 5% valuation discount on unregistered Company equity
instruments due to the restrictions on such instruments.
Cash
Concentration
At
December 31, 2009, 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 $250,000.
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.
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.
In June
2006, the Company adopted provisions of a standard regarding uncertain tax
positions issued by the Financial Accounting Standards Board (“FASB”). These
provisions prescribe 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. The provisions were effective for fiscal
years beginning after December 15, 2006. We adopted the
provisions on July 1, 2007. 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 adoption 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).
Research
and Development
Research
and development expenses include clinical trial costs, costs for outside
consultants and contractors, and costs related to insurance for the Company’s
research and development activities. The Company recognizes such costs as
expense when they are incurred.
7
Clinical Trial
Expenses
We
believe the accrual for clinical trial expenses is a significant estimate used
in the preparation of our condensed consolidated financial statements. Our
accruals for clinical trial expenses are based in part on estimates of services
received and efforts expended pursuant to agreements established with clinical
research organizations and clinical trial sites. We have a history of
contracting with third parties that perform various clinical trial activities on
our behalf in the ongoing development of our biopharmaceutical drugs. The
financial terms of these contracts are subject to negotiations and may vary from
contract to contract and may result in uneven payment flows. We determine our
estimates through discussion with internal clinical personnel and outside
service providers as to progress or stage of completion of trials or services
and the agreed upon fee to be paid for such services. The objective of our
clinical trial accrual policy is to reflect the appropriate trial expenses in
our financial statements by matching period expenses with period services and
efforts expended. In the event of early termination of a clinical trial, we
accrue expenses associated with an estimate of the remaining, non-cancelable
obligations associated with the winding down of the trial. Our estimates and
assumptions for clinical trial expenses have been materially accurate in the
past.
Comprehensive
Income (Loss)
The
Company reports comprehensive income (loss) in accordance with the provisions of
FASB Accounting Standards Codification (“ASC”) Topic 220 (“ASC 220”) (previously
listed as SFAS 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)
consist of net income (loss) and foreign currency translation adjustments.
Comprehensive income (loss) and the components of accumulated other
comprehensive income (loss) are as follows:
Period
from
|
||||||||||||
Three
Months
|
Six
Months
|
July
18, 2005
|
||||||||||
Ended
|
Ended
|
(date
of inception)
|
||||||||||
December
31,
|
December
31,
|
to
December 31,
|
||||||||||
2009
|
2009
|
2009
|
||||||||||
Net
loss
|
$ | (1,007,964 | ) | $ | (956,482 | ) | $ | (12,849,995 | ) | |||
Foreign
currency translation adjustments, net of tax
|
- | - | 20,120 | |||||||||
Comprehensive
loss
|
$ | (1,007,964 | ) | $ | (956,482 | ) | $ | (12,829,875 | ) | |||
Stock-Based
Compensation
The
Company accounts for stock-based compensation in accordance with FASB ASC Topic
718 “Accounting for Compensation Arrangements” (“ASC 718”) (previously listed as
SFAS No. 123 (revised 2004), “Share-Based Payment”) 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 FASB ASC Topic 505-50 “Equity-Based Payments to
Non-Employees” (“ASC 505-50”) (previously listed as 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 to non employees at
fair value of the consideration received or the fair value of the equity
instruments issued as they vest over a service period.
Stock-based
compensation expense is recognized based on awards expected to vest, and
forfeitures were estimated at 5%. ASC 718 requires forfeitures to be
estimated at the time of grant and revised in subsequent periods, if necessary,
if actual forfeitures differ from those estimates.
Recent
Accounting Pronouncements
In
December 2007, FASB issued FASB ASC Topic 810, “Consolidation” (“ASC 810”)
(previously SFAS 160, “Noncontrolling Interests in Consolidated Financial
Statements, an amendment of ARB No. 51”). ASC 810 will change the
accounting and reporting for minority interests which will be recharacterized as
noncontrolling interests and classified as a component of equity. ASC 810 is
effective for fiscal years beginning on or after December 15, 2008. ASC 810
requires retroactive adoption of presentation and disclosure requirements for
existing minority interests. There was no impact upon adoption of ASC 810 on our
condensed consolidated financial statements.
In
December 2007, FASB issued FASB ASC Topic 808, “Collaborative Agreement” (“ASC
808”) (previously EITF 07-01, “Accounting for Collaborative
Arrangements”). 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. This issue is effective for
financial statements issued for fiscal years beginning after December 15, 2008
and is to be applied retrospectively for all collaborative arrangements existing
as of the effective
date. There was no impact upon adoption of ASC 808 on our condensed
consolidated financial statements and its effects on future periods will depend
on the nature and extent of collaborative agreements that we complete, if any,
in or after fiscal year 2010.
8
In July
2008, FASB issued FASB ASC Topic 815, “Derivatives and Hedging” (“ASC 815”)
(previously EITF 07-5, "Determining Whether an Instrument (or an Embedded
Feature) is Indexed to an Entity's Own Stock"). This issue was added to the
EITF's agenda with the purpose of providing an overall framework for determining
whether an instrument is indexed to an entity's own stock and whether such
instruments or embedded features are classified as equity or a liability.
This issue is effective for financial statements issued for fiscal years
beginning after December 15, 2008, and interim periods within those fiscal
years. The adoption of ASC 815 on July 1, 2009 resulted in a decrease of
$1,127,557 to additional paid-in-capital, an increase to accumulated deficit of
$106,318 and an increase to liabilities of $945,549 on the Company’s condensed
consolidated balance sheet. Accordingly, the Company recognized a
$218,326 gain from the change in fair value of these warrants for the three
months ended September 30, 2009. See Note 12.
In June
2009, the FASB issued SFAS No. 168, "The FASB Accounting Standards Codification
and the Hierarchy of Generally Accepted Accounting Principles, a replacement of
FASB Statement No. 162" ("SFAS 168") (now required to be listed as FASB ASC
topic 105), which approved the FASB Accounting Standards Codification
("Codification") as the single source of authoritative GAAP and
reporting standards for all non-governmental entities, except for guidance
issued by the Securities and Exchange Commission. The Codification, which
changes the referencing of financial standards, is effective for interim or
annual financial periods ending after September 15, 2009. The Company applied
the Codification beginning in the first quarter of fiscal year 2010; however,
references to both current GAAP and the Codification are included in this
filing. We have determined that there is no impact from adopting the
Codification on our condensed consolidated financial statements.
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 the University of California, San Diego for certain patent
rights.
The
agreement with the University of California, San Diego was for a license
previously licensed to Urigen, Inc. In exchange for this license, the
Company issued 1,846,400 common shares and is required to make annual
maintenance payments of $20,000 per year through 2010 and then $25,000 per
year thereafter and milestone payments of up to $625,000, which are based on
certain events related to FDA approval. 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, the Company may terminate the
license agreement at any time and for any reason upon a 90-day written
notice.
On August
24, 2009, Urigen, N.A., Inc. the wholly owned subsidiary of Urigen
Pharmaceuticals, Inc. entered into Amendment No.3 (the “Amendment”) to the
certain License Agreement effective June 6, 2004 between Urigen N.A and the
Regents of the University of California (the “University”) for Invention Docket
Nos. SD2003-049 and SD2004-134 “Novel Intravesical Therapy for Immediate Symptom
Selief and Chronic Therapy in Interstitial Cystitis Patients.” Pursuant to the
terms of the Amendment, the license maintenance fees were amended to provide for
future payments of $20,000 on June 6, 2010 and $25,000 on June 6, 2011 and
annually thereafter on each anniversary; provided however that the Company’s
obligation to pay license maintenance fees will end on the date the Company is
commercially selling the licensed product.
The Amendment provides that as partial
consideration and in lieu of cash for license maintenance fees that were due on
May 6, 2009 and June 6, 2009, the Company shall issue 250,000 shares of its
common stock to the University. The shares were issued on November 6,
2009.
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 net residual intangible assets, as follows:
Cash
|
$
|
350,000
|
||
Receivable
from Urigen, Inc.
|
120,000
|
|||
(collected
during the period ended June 30, 2006)
|
||||
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
|
||
9
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 1,623,910 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. This milestone was amended on November 11,
2008 to extend this portion of the agreement from three years to four
years.
The
summary of intangible assets acquired and related accumulated amortization as of
December 31, 2009 and June 30, 2009 is as follows:
December
31,
|
June
30,
|
|||||||
2009
|
2009
|
|||||||
Patent
and intellectual property rights
|
$
|
278,637
|
$
|
278,637
|
||||
Less:
Accumulated amortization
|
(55,198
|
)
|
(47,984
|
)
|
||||
Intangible
assets, net
|
$
|
223,439
|
$
|
230,653
|
||||
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 $7,214 for the
three and six months ended December 31, 2009, respectively, which is included in
research and development expense in the accompanying statements of operations.
Future estimated amortization expense is as follows:
Remaining
six months of fiscal year 2010
|
$ | 7,214 | ||
Fiscal
year 2011
|
14,428 | |||
Fiscal
year 2012
|
14,428 | |||
Fiscal
year 2013
|
14,428 | |||
Fiscal
year 2014
|
14,428 | |||
Thereafter
|
158,513 | |||
$ | 223,439 | |||
4.
|
Accrued
Expenses
|
At
December 31, 2009 and June 30, 2009, the accrued expenses were as
follows:
December
31,
|
June
30,
|
|||||||
2009
|
2009
|
|||||||
Accrued
payroll
|
$ | 1,430,760 | $ | 1,206,414 | ||||
Accrued
payroll taxes
|
533,582 | 530,100 | ||||||
Accrued
other
|
598,454 | 569,616 | ||||||
$ | 2,562,796 | $ | 2,306,130 | |||||
5.
|
Contractual
Obligations and Notes Payable
|
On
November 17, 2006, the Company entered into an unsecured promissory note with C.
Lowell Parsons, 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 had issued 11,277 shares of Urigen N.A.
Series B preferred stock, in connection with this note agreement, which was
converted to common stock at the time of the Merger. At December 31,
2009 and June 30, 2009, the Company owed accrued interest expense of $0 and
$42,000, respectively. On October 27, 2009, the Company entered into a Debt
Settlement Agreement with C. Lowell Parsons. Pursuant to the terms of
the Debt Settlement Agreement, this note, together with accrued interest through
October 27, 2009 was converted to subscribed common stock at $0.10 per
share. See debt conversion section below for
amounts.
10
On
January 5, 2007, the Company entered into an unsecured promissory note with KTEC
Holdings, Inc. in the amount of $100,000. Tracy Taylor who was the Company’s
Chairman of the Board of Directors at the time, was President and Chief
Executive Officer of the Kansas Technology Enterprise Corporation
(KTEC). 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 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
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 had issued 5,639 shares of Urigen N.A. Series B preferred
stock in connection with this note agreement, which was converted to common
stock at the time of the Merger. If this note is not paid when due,
interest shall accrue thereafter at the rate of 18% per annum. At
December 31, 2009 and June 30, 2009, the Company owed accrued interest expense
of $0 and $23,236, respectively. On October 26, 2009, the Company entered into a
Debt Settlement Agreement with KTEC Holdings, Inc. Pursuant to the terms of the
Debt Settlement Agreement, this note, together with accrued interest through
October 26, 2009 was converted to subscribed common stock at $0.10 per
share. See debt conversion section below for amounts.
On June
25, 2007, Valentis, Inc., 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. This note was assumed by the Company pursuant to the Merger.
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. On August 11, 2008, the note was
extended through December 25, 2008. On January 6, 2009, the note was
extended through December 25, 2009. On February 2, 2010 the note was
extended through December 25, 2010. Dr. McGraw was a member of the
Board of Directors as of June 30, 2009 and resigned from the Board of Directors
in July 2009. At December 31, 2009 and June 30, 2009, the Company
owed accrued interest expense of $22,000 and $17,600, respectively.
On August
6, 2008, the Company entered into an unsecured promissory note with C. Lowell
Parsons, M.D. a director of the Company, in the amount of $40,000. 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 15% simple interest. The note allows for
an adjustment of the interest rate equal to that of the rate that the Company
procures from a bridge loan of a minimum of $300,000. The
note is due and payable on the earlier of (i) forty-five (45) days after
consummation of a merger, (ii) the completion of a licensing agreement with a
pharmaceutical partner or (iii) two calendar years from the note issuance
date. The Company may, in its discretion, pay this note in whole or
part at any time, without premium or penalty. Dr. Parsons may, in his
discretion, request payment of this note, in whole or in part in restricted
common stock of the Company. The rate of repayment in common stock is
based on $0.15 per share. At December 31, 2009 and June 30, 2009, the
Company owed accrued interest expense of $0 and $5,417 respectively. On October
27, 2009, the Company entered into a Debt Settlement Agreement with C. Lowell
Parsons. Pursuant to the terms of the Debt Settlement Agreement, this
note, together with accrued interest through October 27, 2009 was converted to
subscribed common stock at $0.10 per share. See debt conversion
section below for amounts.
On August
6, 2008, the Company entered into an unsecured promissory note with J. Kellogg
Parsons, M.D. the son of C. Lowell Parsons, M.D., a director of the Company, in
the amount of $20,000. 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
15% simple interest. The note allows for an adjustment of the
interest rate equal to that of the rate that the Company procures from a bridge
loan of a minimum of $300,000. The foregoing amount is due and
payable on the earlier of (i) forty-five (45) days after consummation of a
merger, (ii) the completion of a licensing agreement with a pharmaceutical
partner or (iii) two calendar years from the note issuance date. The
Company may, in its discretion, pay this note in whole or part at any time,
without premium or penalty. Dr. Parsons may, in his discretion,
request payment of this note, in whole or in part in restricted common stock of
the Company. The rate of repayment in common stock is based on $0.15
per share. All principal amounts due under the note agreement are
still outstanding as of December 31, 2009. At December 31, 2009 and June 30,
2009, the Company owed accrued interest expense of $4,208 and $2,708
respectively. On February 1, 2010, the Company entered into a Debt
Settlement Agreement with J. Kellogg Parsons. Pursuant to the terms
of the Debt Settlement Agreement, this note, together with accrued interest
through January 31, 2010 was converted to subscribed common stock at $0.10 per
share as fully described in the Subsequent Events footnote.
On August
12, 2008, the Company entered into an unsecured promissory note with William J.
Garner, M.D., the Chief Executive Officer and a director of the Company, in the
amount of $5,000. 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 15% simple
interest. The note allows for an adjustment of the interest rate
equal to that of the rate that the Company procures from a bridge loan of a
minimum of $300,000. The foregoing amount is due and payable on the
earlier of (i) forty-five (45) days after consummation of a merger, (ii) the
completion of a licensing agreement with a pharmaceutical partner or (iii) two
calendar years from the note issuance date. The Company may, in its
discretion, pay this note in whole or part at any time, without premium or
penalty. At December 31, 2009 and June 30, 2009, the Company owed
accrued interest expense of $0 and $665 respectively. On October 26, 2009, the
Company entered into a Debt Settlement Agreement with William J.
Garner. Pursuant to the terms of the Debt Settlement Agreement, this
note, together with accrued interest through October 26, 2009 was converted to
subscribed common stock at $0.10 per share. See debt conversion
section below for amounts.
11
On
September 19, 2008, the Company entered into an unsecured promissory note with
William J. Garner, M.D., the Chief Executive Officer and a director of the
Company, in the amount of $20,000. 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 15% simple interest. The note allows for an adjustment of
the interest rate equal to that of the rate that the Company procures from a
bridge loan of a minimum of $300,000. The foregoing amount is due and
payable on the earlier of (i) forty-five (45) days after consummation of a
merger, (ii) the completion of a licensing agreement with a pharmaceutical
partner or (iii) two calendar years from the note issuance date. The
Company may, in its discretion, pay this note in whole or part at any time,
without premium or penalty. At December 31 and June 30, 2009, the
Company owed accrued interest expense of $0 and $2,342 respectively. On October
26, 2009, the Company entered into a Debt Settlement Agreement with William J.
Garner. Pursuant to the terms of the Debt Settlement Agreement, this
note, together with accrued interest through October 26, 2009 was converted to
subscribed common stock at $0.10 per share. See debt conversion
section below for amounts.
On
September 22, 2008, the Company entered into an unsecured promissory note with
C. Lowell Parsons, M.D. a director of the Company, in the amount of $30,000.
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 15% simple interest. The note
allows for an adjustment of the interest rate equal to that of the rate that the
Company procures from a bridge loan of a minimum of $300,000. The
note is due and payable on the earlier of (i) forty-five (45) days after
consummation of a merger, (ii) the completion of a licensing agreement with a
pharmaceutical partner or (iii) two calendar years from the note issuance
date. The Company may, in its discretion, pay this note in whole or
part at any time, without premium or penalty. Dr. Parsons may, in his
discretion, request payment of this note, in whole or in part in restricted
common stock of the Company. The rate of repayment in common stock is
based on $0.15 per share. At December 31, 2009 and June 30, 2009, the
Company owed accrued interest expense of $0 and $3,475
respectively. On October 27, 2009, the Company entered into a Debt
Settlement Agreement with C. Lowell Parsons. Pursuant to the terms of
the Debt Settlement Agreement, this note, together with accrued interest through
October 27, 2009 was converted to subscribed common stock at $0.10 per
share. See debt conversion section below for amounts.
On
September 25, 2008, the Company entered into an unsecured promissory note with
C. Lowell Parsons, M.D. a director of the Company, in the amount of $70,000.
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 15% simple interest. The note
allows for an adjustment of the interest rate equal to that of the rate that the
Company procures from a bridge loan of a minimum of $300,000. The
note is due and payable on the earlier of (i) forty-five (45) days after
consummation of a merger, (ii) the completion of a licensing agreement with a
pharmaceutical partner or (iii) two calendar years from the note issuance
date. The Company may, in its discretion, pay this note in whole or
part at any time, without premium or penalty. Dr. Parsons may, in his
discretion, request payment of this note, in whole or in part in restricted
common stock of the Company. The rate of repayment in common stock is
based on $0.15 per share. At December 31, 2009 and June 30, 2009, the
Company owed accrued interest expense of $0 and $8,021
respectively. On October 27, 2009, the Company entered into a Debt
Settlement Agreement with C. Lowell Parsons. Pursuant to the terms of
the Debt Settlement Agreement, this note, together with accrued interest through
October 27, 2009 was converted to subscribed common stock at $0.10 per
share. See debt conversion section below for amounts.
On
October 6, 2008, the Company entered into an unsecured promissory note with a
third party, in the amount of $20,000. 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 15% simple interest. The note allows for an adjustment of the interest
rate equal to that of the rate that the Company procures from a Bridge Loan of a
minimum of $300,000. The note is due and payable on the
earlier of (i) forty-five (45) days after consummation of a merger, (ii) the
completion of a licensing agreement with a pharmaceutical partner or (iii) two
(2) calendar years from the note issuance date. The Company may, in
its discretion, pay this note in whole or part at any time, without premium or
penalty. The note holder may, in their discretion, request payment of
this note, in whole or in part in restricted common stock of the
Company. The rate of repayment in common stock is based on $0.15 per
share. All principal amounts due under the note agreement are still outstanding
as of December 31, 2009. At December 31, 2009 and June 30, 2009, the
Company owed accrued interest expense of $3,708 and $2,208
respectively.
The
Company entered into a note purchase agreement (the “Note”) dated as of January
9, 2009 with Platinum-Montaur Life Science, LLC (“Platinum” or the “Holder”) for
the sale of 10% senior secured convertible promissory notes in the aggregate
principal amount of $257,000. The Note originally provided for a maturity date
of October 9, 2009 which was extended on October 26, 2009 through April 9, 2010.
Interest at the rate of 10% per annum is payable quarterly commencing April 1,
2009 and on the maturity date. Interest is payable at the option of the Company,
in cash or in registered shares of the Company’s stock under certain conditions.
However, the Company may not issue shares toward the payment of interest in
excess of 20% of the aggregate dollar trading volume of the Company’s stock over
the 20 consecutive trading days immediately prior to the interest payment
date. As of December 31, 2009 and June 30, 2009, the Company owed
accrued interest expense of $26,372 and $13,125, respectively. The
Note currently is convertible into shares of the Company’s common stock at
a conversion price of $0.10 per share.
Pursuant
to the terms of the Note, events of default include, but are not limited to: (i)
failure to pay principal or any payments due under the Note or to timely deliver
any shares of common stock upon conversion of the Note or any interest, (ii)
failure to comply with any covenant or agreement contained in the Note, the
purchase agreement or any other document executed in connection with the
purchase agreement, (iii) suspension of listing or failure to be listed on at
least the OTC Bulletin Board, the AMEX, the NASDAQ Capital Markers, the NASDAQ
Global Market, the NASDAQ Global Select Market or the NYSE for a period of 5
consecutive trading days, (iv) the Company’s notice to the Holder of its
inability to comply or its intention not to comply with requests for conversion
of the Note into shares of the Company’s common stock, (v) failure of the
Company to instruct its transfer agent to remove any legends from shares
eligible to be sold under Rule 144 and issued such clean stock certificates
within 3 business days of the Holder’s request, (vi) the Company shall apply for
or consent to the appointment of or the taking of possession by a receiver,
custodian, trustee or liquidator or makes a general assignment for the benefit
of its creditors or commences a voluntary case of bankruptcy, files a petition
seeking protection of bankruptcy, insolvency, moratorium, reorganization or
other similar law, acquiesces in the filing of a petition against it in an
involuntary case under the United States Bankruptcy Code, issues a notice of
bankruptcy or winding down of its operations or issues a press release regarding
same.
12
In
addition to the foregoing:
·
|
The
Company granted to Platinum the right to subscribe for an additional
amount of securities of the Company in any subsequent financing conducted
by the Company for the period commencing on the closing date of this Note
through the date the Note is repaid. In addition, if the Company enters
into any subsequent financing on terms more favorable than the terms of
the Note then the Holder has the option to exchange the Note together with
accrued and unpaid interest for the securities to be issued in the
subsequent financing.
|
·
|
The
Company agreed not to issue any variable equity securities, as such term
is defined in the purchase agreement, unless the Company receives the
prior written approval of Platinum. Variable equity securities include,
but are not limited to, (A) any debt or equity securities which are
convertible into, exercisable or exchangeable for, or carry the right to
receive additional shares of common stock, (B) any amortizing
convertible security which amortizes prior to its maturity date, where the
Company is required to or has the option to make such amortization payment
in shares of common stock, or (C) any equity line
transaction.
|
·
|
The
Company granted Platinum piggy-back registration rights in connection with
the shares of common stock issuable upon conversion of the
Note.
|
·
|
The
Company has agreed to reserve 120% of the number of shares into which the
Note is convertible.
|
·
|
As
security for the payment of the Note the Company and its wholly owned
subsidiary, Urigen, N.A., Inc. (“Urigen N.A.”) entered into a security
agreement and patent, trademark and copyright security agreement pursuant
to which they pledged all of their assets. In addition, Urigen N.A.
executed a guaranty guaranteeing the obligations of the Company under the
purchase agreement.
|
·
|
The
terms of the Note provide that it may not be converted if such exercise
would result in the Holder having beneficial ownership of more than 4.99%
of the Company’s outstanding common stock; provided that the Holder may
waive this provision upon 61 days notice; and provided further that such
ownership limitation may not exceed
9.9%.
|
·
|
In
the event that the Company issues or sells any additional shares of common
stock or any rights or warrants or options to purchase shares at a price
that is less than the conversion price, then the conversion price shall be
adjusted to the lower price at which such additional shares were issued or
sold. The Company will not be required to make any adjustment to the
conversion price in connection with (A) issuances of shares of common
stock or options to its employees, officers or directors pursuant to any
existing stock or option plan, (B) securities issued pursuant to
acquisitions or strategic transactions or (C) issuances of
securities upon the exercise or exchange of or conversion of the Note and
other securities exercisable or exchangeable for or convertible into
shares of common stock issued and outstanding as of the date of the
purchase agreement.
|
·
|
In
the event of a default as described in the Note, the Holder shall have the
right to require the Company to repay in cash all or a portion of the Note
plus all accrued but unpaid interest at a price of 110% of the aggregate
principal amount of the Note plus all accrued and unpaid
interest.
|
The
issuance of this Note resulted in a change to the conversion price per share of
the Series B Convertible Preferred Stock issued pursuant to the terms of the
Series B Convertible Preferred Stock Purchase Agreement dated as of July 31,
2007 (see Note 6).
On
January 21, 2009, the Company entered into an unsecured non interest bearing
convertible promissory note of $50,000 with a third party. The note
matured on December 31, 2009. Under the terms of the note, the third party will
perform consulting services for the Company. Under the terms of the
note, the Company may prepay in whole or in part without premium or penalty, at
any time. At any time prior to or at the time of prepayment of this
note, the holder may elect to convert some or all of the principal owing under
this note into shares of the Company’s common stock at the rate of $0.02 per
share. The holder’s right to convert the obligations due under this
note to common stock shall supersede the Company’s right to repay such
obligations in cash. The conversion rate of this note generated a beneficial
conversion feature that resulted in a note discount of $50,000. The note
discount was amortized as additional interest expense over the term of the
note. On February 3, 2010, the note was converted into 2.5 million
shares of the Company’s common stock.
13
On April
28, 2009, the Company entered into an Amendment (the “Amendment”) to the Note
Purchase Agreement dated as of January 9, 2009 with Platinum-Montaur Life
Science, LLC. Pursuant to the Amendment the Company issued a 10% senior secured
convertible promissory note in the principal amount of $40,000. This note
originally provided for a maturity date of October 9, 2009, which was extended
on October 26, 2009 through April 9, 2010. The terms of this note are the same
as the Note issued by the Company pursuant to the note purchase agreement on
January 9, 2009. It is stipulated in this note that the proceeds
shall be used by the Company to retain CEOcast, Inc. to render investor
relations services. At December 31, 2009 and June 30, 2009, the Company
owed accrued interest expense of $2,807 and $700, respectively.
On June
12, 2009, the Company entered into an unsecured promissory note with C. Lowell
Parsons, M.D. a director of the Company, in the amount of $15,000. 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 15% simple interest. The note allows for
an adjustment of the interest rate equal to that of the rate that the Company
procures from a bridge loan of a minimum of $300,000. The note is due
and payable on the earlier of (i) forty-five (45) days after consummation of a
merger, (ii) the completion of a licensing agreement with a pharmaceutical
partner or (iii) two calendar years from the note issuance date. The
Company may, in its discretion, pay this note in whole or part at any time,
without premium or penalty. Dr. Parsons may, in his discretion,
request payment of this note, in whole or in part in restricted common stock of
the Company. The rate of repayment in common stock is based on $0.15
per share. At December 31, 2009 and June 30, 2009, the Company owed
accrued interest expense of $0 and $113, respectively. On October 27, 2009, the
Company entered into a Debt Settlement Agreement with C. Lowell
Parsons. Pursuant to the terms of the Debt Settlement Agreement, this
note, together with accrued interest through October 27, 2009 was converted to
subscribed common stock at $0.10 per share. See debt conversion
section below for amounts.
On July
7, 2009, the Company entered into an unsecured promissory note with C. Lowell
Parsons, M.D. a director of the Company, in the amount of $15,000. 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 15% simple interest. The note allows for
an adjustment of the interest rate equal to that of the rate that the Company
procures from a bridge loan of a minimum of $300,000. The note is due
and payable on the earlier of (i) forty-five (45) days after consummation of a
merger, (ii) the completion of a licensing agreement with a pharmaceutical
partner or (iii) two (2) calendar years from the note issuance
date. The Company may, in its discretion, pay this note in whole or
part at any time, without premium or penalty. At December 31, 2009, the
Company owed accrued interest expense of $0. On October 27, 2009, the Company
entered into a Debt Settlement Agreement with C. Lowell
Parsons. Pursuant to the terms of the Debt Settlement Agreement, this
note, together with accrued interest through October 27, 2009 was converted to
subscribed common stock at $0.10 per share. See debt conversion
section below for amounts.
On July
21, 2009, the Company entered into an unsecured promissory note with C. Lowell
Parsons, M.D. a director of the Company, in the amount of $30,000. 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 15% simple interest. The note allows for
an adjustment of the interest rate equal to that of the rate that the Company
procures from a bridge loan of a minimum of $300,000. The note is due
and payable on the earlier of (i) forty-five (45) days after consummation of a
merger, (ii) the completion of a licensing agreement with a pharmaceutical
partner or (iii) two (2) calendar years from the note issuance
date. The Company may, in its discretion, pay this note in whole or
part at any time, without premium or penalty. At December 31, 2009,
the Company owed accrued interest expense of $0. On October 27, 2009, the
Company entered into a Debt Settlement Agreement with C. Lowell
Parsons. Pursuant to the terms of the Debt Settlement Agreement, this
note, together with accrued interest through October 27, 2009 was converted to
subscribed common stock at $0.10 per share. See debt conversion
section below for amounts.
On August
13, 2009, the Company entered into an Amendment No.2 (the “Amendment”) to the
Note Purchase Agreement dated as of January 9, 2009 (the “Purchase Agreement”)
with Platinum-Montaur Life Science, LLC. Pursuant to the Amendment the Company
issued a 10% senior secured convertible promissory note in the principal amount
of $202,500. The Note originally provided for a maturity date of October 9,
2009, which was extended on October 26, 2009 through April 9, 2010. The terms of
the Note are the same as the Note issued by the Company pursuant to the Purchase
Agreement on January 9, 2009. At December 31, 2009 the Company owed
accrued interest expense of $5,436.
On
September 29, 2009, the Company entered into an unsecured promissory note with
C. Lowell Parsons, M.D. a director of the Company, in the amount of $12,000.
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 15% simple interest. The note
allows for an adjustment of the interest rate equal to that of the rate that the
Company procures from a bridge loan of a minimum of $300,000. The
note is due and payable on the earlier of (i) forty-five (45) days after
consummation of a merger, (ii) the completion of a licensing agreement with a
pharmaceutical partner or (iii) two (2) calendar years from the note issuance
date. The Company may, in its discretion, pay this note in whole or
part at any time, without premium or penalty. At December 31, 2009,
the Company owed accrued interest expense of $0. On October 27, 2009, the
Company entered into a Debt Settlement Agreement with C. Lowell
Parsons. Pursuant to the terms of the Debt Settlement Agreement, this
note, together with accrued interest through October 27, 2009 was converted to
subscribed common stock at $0.10 per share. See debt conversion
section below for amounts.
On
November 9, 2009, the Company entered into an unsecured promissory note with C.
Lowell Parsons, M.D. a director of the Company, in the amount of $10,000. 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 15% simple interest. The note
allows for an adjustment of the interest rate equal to that of the rate that the
Company procures from a bridge loan of a minimum of $300,000. The
note is due and payable on the earlier of (i) forty-five (45) days after
consummation of a merger, (ii) the completion of a licensing agreement with a
pharmaceutical partner or (iii) two (2) calendar years from the note issuance
date. The Company may, in its discretion, pay this note in whole or
part at any time, without premium or penalty. All principal amounts
due under the note agreement are still outstanding as of December 31,
2009. At December 31, 2009, the Company owed accrued interest expense
of $214.
14
On
December 4, 2009, the Company entered into an unsecured promissory note with C.
Lowell Parsons, M.D. a director of the Company, in the amount of $16,500. 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 15% simple interest. The note
allows for an adjustment of the interest rate equal to that of the rate that the
Company procures from a bridge loan of a minimum of $300,000. The
note is due and payable on the earlier of (i) forty-five (45) days after
consummation of a merger, (ii) the completion of a licensing agreement with a
pharmaceutical partner or (iii) two (2) calendar years from the note issuance
date. The Company may, in its discretion, pay this note in whole or
part at any time, without premium or penalty. All principal amounts
due under the note agreement are still outstanding as of December 31,
2009. At December 31, 2009, the Company owed accrued interest expense
of $186.
On
December 10, 2009, the Company entered into an unsecured promissory note with C.
Lowell Parsons, M.D. a director of the Company, in the amount of $4,500. 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 15% simple interest. The note
allows for an adjustment of the interest rate equal to that of the rate that the
Company procures from a bridge loan of a minimum of $300,000. The
note is due and payable on the earlier of (i) forty-five (45) days after
consummation of a merger, (ii) the completion of a licensing agreement with a
pharmaceutical partner or (iii) two (2) calendar years from the note issuance
date. The Company may, in its discretion, pay this note in whole or
part at any time, without premium or penalty. All principal amounts
due under the note agreement are still outstanding as of December 31,
2009. At December 31, 2009, the Company owed accrued interest expense
of $42.
Debt
Conversion into Equity
On
October 26, 2009, the Company entered into Debt Settlement Agreements with
William J. Garner, its CEO, and KTEC Holdings, Inc. (“KTEC”). Pursuant to the
terms of the Debt Settlement Agreements, Dr. Garner converted outstanding
unsecured promissory notes in the amount of $25,000 plus accrued interest of
$4,256 into 292,562 shares of subscribed common stock of the Company at a rate
of $0.10 per share. KTEC converted an outstanding unsecured
promissory note of $100,000 plus accrued interest of $28,444 into 1,284,441
shares of subscribed common stock of the Company at a rate of $0.10 per
share.
On
October 27, 2009, the Company entered into a Debt Settlement Agreement with C.
Lowell Parsons, a director of the Company. Pursuant to the terms of the Debt
Settlement Agreement, Dr. Parsons converted outstanding unsecured promissory
notes in the amount of $412,000 plus accrued interest of $76,886 into 4,888,862
shares of subscribed common stock of the Company at a rate of $0.10 per
share.
On
December 29, 2009, the Company entered into a Debt Settlement Agreement with the
Catalyst Law Group APC (“Catalyst Group”). Pursuant to the terms of the Debt
Settlement Agreement, the Catalyst Group agreed to convert the outstanding
amount of $121,342, including accrued interest, owed by the Company into
1,213,419 shares subscribed common stock at a rate of $0.10 per
share.
Contractual
Obligations
On
November 1, 2008, the Company entered into a consulting agreement with FLP
Pharma LLC pursuant to which Mr. Nida would provide consulting services to the
Company for a term commencing on November 1, 2008 through December 31, 2009. The
Consulting Agreement provides for compensation of $200 per hour for a maximum
amount of 50 hours monthly. Also, the Consulting Agreement provided that the
agreement may be terminated by either party upon two weeks prior written notice;
provided however, if the agreement is terminated by Company, the Company would
be obligated to pay to Mr. Nida certain amounts owed pursuant to his employment
agreement with the Company dated as of May 1, 2006. The
agreement was terminated by Mr. Nida in January 2009. As of December
31, 2009, Mr. Nida provided $6,700 of consulting services.
On
November 1, 2008, the Company entered into a consulting agreement with Dennis H.
Giesing pursuant to which Dr. Giesing would provide consulting services to the
Company for a term commencing on November 1, 2008 through November 1, 2009.
Pursuant to the terms of the Consulting Agreement, Dr. Giesing would provide
services to the Company on an “as needed” basis not to exceed 4 days per month
at a rate of $2,000 per day. The Consulting Agreement provided that either party
may terminate the agreement upon written notice. As of December 31,
2009, Dr. Giesing had not provided any consulting services to the
Company.
On
December 18, 2009, the Company entered into Consulting Agreement (the
“Agreement”) with Oceana Therapeutics, Inc. (“Oceana”). The Agreement provides
that Oceana will assist the Company in the development and preparation of a
Phase II meeting with the FDA in connection with URG-101. In addition, Oceana
agreed to pay the fees to the Company’s consultants in connection with the
meeting with the FDA in an amount of up to $50,000. In exchange for the services
to be rendered by Oceana, the Company agreed to provide to Oceana a right of
first refusal to license all indications of URG-101 that may be approved by the
FDA. The term of the Agreement commenced on December 18, 2009 and will continue
through that date that is 60 days after the Company’s meeting with the
FDA.
6.
|
Series
B Convertible Preferred Stock
|
In
December 2005, the SEC published guidance on the application of the FASB ASC
Topic 815, (previously EITF Issue No. 00-19 “Accounting for Derivative Financial
Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock”, in
relation to the effect of cash liquidated damages provisions upon conversion of
convertible equity securities. Due to this interpretation of ASC 815, the
Company classified the $2.1 million July 2007 private placement of Series B
Preferred Stock issued to Platinum-Montaur Life Science, LLC (“Platinum”) as a
liability not equity for the period ended September 30, 2007.
15
The
Company determined that the liquidated damages could result in net-cash
settlement of a conversion. ASC 815 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 ASC 815, 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 ASC 815. The
Company valued the warrants using the Black-Scholes model and recorded
$1,127,557 as a discount to equity. In accordance with ASC 470, 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 ASC 470,
amortized that amount and the relative fair value amount allocated to the
warrants immediately, as the Series B Preferred Stock was immediately
convertible. This amount was included in non-cash interest expense for the
period ended September 30, 2007.
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 ASC 815, 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. Each quarter since, the Company has continued to mark to market
the portion of this financing classified as liability in the accompanying
condensed consolidated balance sheet, in accordance with ASC 815.
As
discussed in Note 5 above, on January 9, 2009, the Company issued secured
convertible notes payable at a lower conversion price than the conversion price
under the July 2007 Series B Convertible Preferred Stock
agreement. This resulted in a change to the conversion price of the
July 2007 Series B Convertible Preferred Stock agreement from $0.15 per share to
$0.10 per share, which upon conversion by the holder of the preferred stock
would result in the conversion to 21 million shares of common stock instead of
14 million shares of common stock as per the terms of the original
agreement. The issuance of the January 9, 2009 note also resulted in
the price reset of the warrant exercise price from $0.18 per share to $0.125 per
share, which would reduce the gross proceeds received upon exercise of the
warrants from $2.52 million to $1.75 million.
The
impact of this modification to the conversion price of the Company’s Series B
Preferred Stock also resulted in a $202,000 incremental beneficial conversion
feature from that originally recorded in the quarter ended September 30, 2007
upon the closing of the July 2007 Series B Convertible Preferred Stock
agreement. This incremental beneficial conversion feature was
allocated by a $14,000 charge to interest expense and an increase in the Series
B convertible beneficial conversion feature liability included in the
accompanying condensed consolidated balance sheet, with the remaining $188,000
resulting in offsetting entries to additional paid-in capital for the portion of
shares registered prior to this new note.
In
addition, as a result of 21 million shares of common stock now being issuable
upon conversion of the July 2007 Series B Convertible Preferred Stock, the
number of unregistered shares under this agreement increased from 880,000 shares
to 7,880,000 shares and thereby, the potential cash settlement the Company would
be required to make if it were unable to issue registered shares upon conversion
also increased. This resulted in a reclassification of $700,000 from
additional paid-in capital to Series B convertible preferred stock
liability. In accordance with ASC 815, the change in fair value of
the agreement during the period the agreement was classified as equity should be
accounted for as an adjustment to equity and therefore, the Company recorded a
$420,000 increase to additional paid-in capital and a decrease to Series B
convertible preferred stock liability to reflect the decrease in fair value of
the Company’s stock from December 13, 2007 to January 9,
2009. Subsequent to the reclassification from equity to liability, in
accordance with ASC 815, the portion now classified as a liability should be
marked to fair value through earnings/loss. Therefore, for the period
from July 1, 2009 to September 30, 2009, a $197,000 mark to market charge
increased other income and decreased the Series B convertible preferred stock
liability. For the quarter ended December 31, 2009, a $275,000 mark
to market charge increased other expense and the Series B Preferred Stock
liability.
The
Company registered 13,120,000 shares of common stock (the “Registered Shares”)
issuable upon conversion of the Series B Preferred Stock in a registration
statement which was declared effective by the SEC on December 13, 2007. The
Company is obligated to file an additional registration statement to register
the additional shares issuable under the Series B Convertible Preferred Stock
Purchase Agreement dated as of July 31, 2007 on , the later of (i) ninety (90)
days following the sale of substantially all of the Registered Shares included
in the initial Registration Statement or any subsequent Registration Statement
and (ii) seven (7) months following the effective date of the initial
Registration Statement or any subsequent Registration Statement, as applicable,
or such earlier date as permitted by the Commission. As of the date of this
report, none of the Registered Shares have been sold therefore the Company is
not at this time required to file an additional registration
statement.
16
7.
|
Subscribed
Common Stock
|
On
November 4, 2009, the Company entered into a Stock Purchase Agreement with a
third party in the amount of $10,000. Under the terms of the
agreement, the individual received 100,000 shares of subscribed common stock of
the Company at the rate of $0.10 per share and the right to purchase 100,000
warrants of the Company at the rate of $0.125 per share. The warrants
have a five year term. From the date of the agreement until the first
anniversary of the agreement, in the event that the Company issues or sells any
shares of Common Stock or any Common Stock Equivalents pursuant to which shares
of Common Stock may be acquired at a price less than $0.10 per share (a "Lower
Price Issuance"), the purchaser shall have the right to elect to substitute any
term or terms of the offering being made in connection with the Lower Price
Issuance for any term of the offering in connection with the Common Stock and
Warrants (purchased hereunder) owned by the subscriber. In accordance
with ASC 815, the warrants were classified as a liability, based on a
Black-Scholes fair value valuation, on the transaction date in the amount of
$8,943, and are marked to market fair value through earnings/loss each
period. A $929 non-cash mark to market expense was recorded for the
quarter ended December 31, 2009.
On
November 9, 2009, the Company entered into a Stock Purchase Agreement with a
third party in the amount of $25,000. Under the terms of the
agreement, the individual received 250,000 subscribed shares of common stock of
the Company at the rate of $0.10 per share and the right to purchase 250,000
warrants of the Company at the rate of $0.125 per share. The warrants
have a five year term. From the date of the agreement until the first
anniversary of the agreement, in the event that the Company issues or sells any
shares of Common Stock or any Common Stock Equivalents pursuant to which shares
of Common Stock may be acquired at a price less than $0.10 per share (a "Lower
Price Issuance"), the purchaser shall have the right to elect to substitute any
term or terms of the offering being made in connection with the Lower Price
Issuance for any term of the offering in connection with the Common Stock and
Warrants (purchased hereunder) owned by the subscriber. In accordance
with ASC 815, the warrants were classified as a liability, based on a
Black-Scholes fair value valuation, on the transaction date in the amount of
$14,723 and are marked to market fair value through earnings/loss each
period. A $9,954 non-cash mark to market expense was recorded for the
quarter ended December 31, 2009.
8.
|
Stock-Based
Compensation
|
The
Company accounts for stock-based compensation in accordance with FASB ASC Topic
718 “Accounting for Compensation Arrangements” (“ASC 718”) (previously listed as
SFAS No. 123 (revised 2004)), “Share-Based Payment”, 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 FASB ASC Topic 505-50 “Equity-Based Payments to
Non-Employees” (“ASC 505-50”) (previously listed as 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 to non employees at
fair value of the consideration received or the fair value of the equity
instruments issued as they vest over a service period.
The
Company assumed the outstanding stock options and plans of its predecessor,
Valentis, at the time of the Merger, July 13, 2007, and has continued to record
stock-based compensation expense for those options as they have
vested. There have not been any exercises nor any new awards under
these prior plans. There were no unvested options as of December 31,
2009. These options expire after 10 years or 90 days after
termination of service (1 year after termination of service for the Non-Employee
Directors Plan) and are expected to fully vest or expire by June 30, 2010. The
expense recorded for assumed options, employee restricted stock awards, and
stock compensation to directors was immaterial for the three and six month
period ended December 31, 2009 and is expected to remain immaterial in future
periods. No grants occurred in the three month period ending December
31, 2009. No expirations or cancellations occurred in this
period.
9.
|
Net
Income (Loss) Per Share
|
Basic net
income (loss) per share is computed by dividing net income (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 income
(loss) per share follows:
Three months ended | Six months ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2009
|
2008
|
2009
|
2008
|
|||||||||||||
Net
Income (loss)
|
$ | (1,007,964 | ) | $ | (430,972 | ) | $ | (956,482 | ) | $ | (892,968 | ) | ||||
Net
income (loss) attributable to common stockholders
|
$ | (1,026,229 | ) | $ | (430,972 | ) | $ | (992,786 | ) | $ | (892,968 | ) | ||||
Net
income (loss) attributable per common share:
|
||||||||||||||||
Basic
|
$ | (0.01 | ) | $ | (0.01 | ) | $ | (0.01 | ) | $ | (0.01 | ) | ||||
Diluted
|
$ | (0.01 | ) | $ | (0.01 | ) | $ | (0.01 | ) | $ | (0.01 | ) | ||||
Weighted
average number of common shares outstanding:
|
||||||||||||||||
Basic
|
79,887,257 | 72,214,441 | 77,006,988 | 72,108,272 | ||||||||||||
Diluted
|
79,887,257 | 72,214,441 | 77,006,988 | 72,108,272 | ||||||||||||
17
As of
December 31, 2009 and 2008, respectively, approximately 18.6 million and 22.0
million options, warrants, and restricted stock had been excluded from the
calculation of diluted loss per share as the effect would have been
antidilutive.
10.
|
Related
Party Transactions
|
As of
December 31, 2009 and 2008, the Company is paying a fee of $1,083 and $3,211 per
month to EGB Advisors, LLC. EGB Advisors, LLC is owned solely by William J.
Garner, M.D. Chief Executive Officer of the Company. The fees are for
rent, telephone and other office services which are based on estimated fair
market value. As of December 31, 2009 and June 30, 2009, Dr. Garner
and EGB Advisors, LLC were owed $4,084 and $6,007, respectively. From the
inception of the Company to December 31, 2009 and 2008, respectively, the
Company has paid $198,231 and $183,216 to these related parties, $4,256 of which
was paid in common stock at $0.10 per share.
Several
stockholders provided consulting services and were paid $174,208 and $171,708
for those services from the inception of the Company to December 31, 2009 and
2008, respectively. As of December 31, 2009 and June 30, 2009,
respectively, $456 and $456 was owed to these consultants.
As of
December 31, 2009 and June 30, 2009, the Company’s former legal counsel in
Canada was owed $67,169 and $67,169, respectively. From the inception
of the Company to December 31, 2009 and 2008, the Company paid $78,299 and
$78,299, respectively, for legal expenses to the related party
stockholders’ company.
As of
December 31, 2009 and June 30, 2009, the Company’s former legal counsel was owed
$0 and $102,861, respectively. From the inception of the Company to December 31,
2009 and 2008, the Company paid $294,667 and $173,325, respectively, for legal
expenses to the related party stockholder’s company. On December 29,
2009 the Company entered into a Debt Settlement Agreement with this former legal
counsel. Pursuant to the terms of the Debt Settlement Agreement, the former
legal counsel agreed to convert the outstanding amount of $121,342, including
accrued interest, owed by the Company into 1,213,419 shares of its common stock
at a rate of $0.10 per share.
On August
27, 2007, the Company settled a debt with one of its former legal
counsels. As part of the settlement, the Company paid $15,132 on
behalf of Inverseon, Inc. William J. Garner, M.D., the Chief
Executive Officer and a director and Martin E. Shmagin, the Chief Financial
Officer and a director are also officers, directors and shareholders in
Inverseon, Inc. On August 22, 2008, Inverseon, Inc. converted its
$15,132 receivable to an unsecured promissory note. From the inception of the
Company to December 31, 2009, Inverseon has paid the Company $1,000 in interest
income. As of December 31, 2009, $1,412 of accrued interest was due the
Company.
11.
|
Fair
Value Measurements
|
Effective
July 1, 2008, the Company adopted fair value measurement guidance issued by
the FASB which define fair value as the exchange price that would be received
for an asset or paid to transfer a liability (an exit price) in the principal or
most advantageous market for the asset or liability in an orderly transaction
between market participants at the measurement date. This guidance establishes a
three-level fair value hierarchy that prioritizes the inputs used to measure
fair value. This hierarchy requires entities to maximize the use of observable
inputs and minimize the use of unobservable inputs. The three levels of inputs
used to measure fair value are as follows:
·
|
Level
1 —Quoted prices in active markets for identical assets or
liabilities.
|
·
|
Level
2 — Observable inputs other than quoted prices included in Level 1, such
as quoted prices for similar assets and liabilities in active markets;
quoted prices for identical or similar assets and liabilities in markets
that are not active; or other inputs that are observable or can be
corroborated by observable market
data.
|
·
|
Level
3 — Unobservable inputs that are supported by little or no market activity
and that are significant to the fair value of the assets or liabilities.
This includes certain pricing models, discounted cash flow methodologies
and similar valuation techniques that use significant unobservable
inputs.
|
The
Company's adoption of these changes did not have a material impact on its
condensed consolidated financial statements. The Company has segregated all
financial assets and liabilities that are measured at fair value on a recurring
basis (at least annually) into the most appropriate level within the fair value
hierarchy based on the inputs used to determine the fair value at the
measurement date in the table below. FASB guidance delayed the
effective date for all nonfinancial assets and liabilities until fiscal years
beginning after November 15, 2008 and interim periods within those fiscal years,
except for those that are recognized or disclosed at fair value in the financial
statements on a recurring basis.
18
Assets
and liabilities measured at fair value on a recurring basis as of December 31,
2009 and June 30, 2009 are summarized below:
December
31, 2009
|
June
30, 2009
|
||||||||||||||||||||||||
Level
1
|
Level
2
|
Total
|
Level
1
|
Level
2
|
Total
|
||||||||||||||||||||
Assets:
|
|||||||||||||||||||||||||
Cash
|
$
|
401
|
$
|
-
|
$
|
401
|
$
|
2,805
|
$
|
-
|
$
|
2,805
|
|||||||||||||
Liabilities:
|
|||||||||||||||||||||||||
Series
B Convertible Preferred Stock, unregistered portion classified as a
liability
|
$
|
-
|
$
|
788,000
|
$
|
788,000
|
$
|
-
|
$
|
709,200
|
$
|
709,200
|
|||||||||||||
Warrants
Liability
|
$
|
-
|
$
|
1,395,038
|
$
|
1,395,038
|
$
|
-
|
$
|
-
|
$
|
-
|
|||||||||||||
12.
|
Warrants
|
Effective
July 1, 2009, the Company adopted the provisions of FASB ASC Topic 815,
“Derivatives and Hedging” (“ASC 815”) (previously EITF 07-5, "Determining
Whether an Instrument (or an Embedded Feature) is Indexed to an Entity's Own
Stock"). As a result of adopting ASC 815, warrants to purchase 14,000,000 of the
Company's common stock previously treated as equity pursuant to the derivative
treatment exemption were no longer afforded equity treatment. These warrants
have an exercise price of $0.125 and expire in July 2012. Effective July 1, 2009
the Company reclassified the fair value of these common stock purchase warrants,
from equity to liability status, as if these warrants were treated as a
derivative liability since their date of issue. On July 1, 2009, the Company
reclassified the effects of prior accounting for the warrants by decreasing
additional paid-in capital by $1,127,557, increasing accumulated deficit by
$106,318, and recording a $1,233,875 warrant liability. The fair value of these
common stock purchase warrants increased to $1,360,488 as of December 31, 2009.
Accordingly, the Company recognized a $288,326 gain and a $126,613 loss from the
change in fair value of these warrants for the three and six months ended
December 31, 2009. The fair value was calculated using the
Black-Scholes option pricing model. The assumptions that were used to calculate
fair value as of July 1, 2009 and December 31, 2009 for these warrants and the
warrants issued in the quarter ended December 31, 2009 described in Note 7 were
as follows:
Expiration
Date
|
||||||||||||
July
2012
|
||||||||||||
Assumption
as of July 1, 2009:
|
||||||||||||
Risk-free
interest rate
|
1.64 | % | ||||||||||
Expected
volatility
|
271.21 | % | ||||||||||
Expected
life (in years)
|
3.04 | |||||||||||
Dividend
yield
|
0.00 | % | ||||||||||
Expiration
Date
|
Expiration
Date
|
Expiration
Date
|
||||||||||
July
2012
|
August
2014
|
October
2014
|
||||||||||
Assumption
as of December 31, 2009:
|
||||||||||||
Risk-free
interest rate
|
1.70 | % | 2.69 | % | 2.69 | % | ||||||
Expected
volatility
|
280.28 | % | 232.82 | % | 228.44 | % | ||||||
Expected
life (in years)
|
2.53 | 4.63 | 4.82 | |||||||||
Dividend
yield
|
0.00 | % | 0.00 | % | 0.00 | % |
13.
|
Subsequent
Events
|
The
Company’s management has evaluated and disclosed subsequent events from the
balance sheet date of December 31, 2009 through February 15, 2010, the day
before the date that these financial statements were filed with the Securities
and Exchange Commission in this Quarterly Report on Form 10-Q.
On
January 5, 2010, the Company entered into an unsecured promissory note with C.
Lowell Parsons, M.D. a director of the Company, in the amount of $20,000. 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 15% simple interest. The note
allows for an adjustment of the interest rate equal to that of the rate that the
Company procures from a bridge loan of a minimum of $300,000. The
note is due and payable on the earlier of (i) forty-five (45) days after
consummation of a merger, (ii) the completion of a licensing agreement with a
pharmaceutical partner or (iii) two (2) calendar years from the note issuance
date. The Company may, in its discretion, pay this note in whole or
part at any time, without premium or penalty.
On
January 11, 2010, the Company entered into a Stock Purchase Agreement with a
third party in the amount of $25,000. Under the term of the
agreement, the individual received 250,000 shares of subscribed common stock of
the Company at the rate of $0.10 per share and the right to purchase 250,000
warrants of the Company at the rate of $0.125 per share. The warrants
have a five year expiration date. From the date of the agreement
until the first anniversary of the agreement, in the event that the Company
issues or sells any shares of Common Stock or any Common Stock Equivalents
pursuant to which shares of Common Stock may be acquired at a price less than
$0.10 per share (a "Lower Price Issuance"), the purchaser shall have the right
to elect to substitute any term or terms of the offering being made in
connection with the Lower Price Issuance for any term of the offering in
connection with the Common Stock and Warrants (purchased hereunder) owned by the
subscriber.
19
On
January 12, 2010, the Company entered into a Stock Purchase Agreement with a
third party in the amount of $25,000. Under the term of the
agreement, the individual received 250,000 shares of subscribed common stock of
the Company at the rate of $0.10 per share and the right to purchase 250,000
warrants of the Company at the rate of $0.125 per share. The warrants
have a five year expiration date. From the date of the agreement
until the first anniversary of the agreement, in the event that the Company
issues or sells any shares of Common Stock or any Common Stock Equivalents
pursuant to which shares of Common Stock may be acquired at a price less than
$0.10 per share (a "Lower Price Issuance"), the purchaser shall have the right
to elect to substitute any term or terms of the offering being made in
connection with the Lower Price Issuance for any term of the offering in
connection with the Common Stock and Warrants (purchased hereunder) owned by the
subscriber.
On
January 13, 2010, the Company entered into a Stock Purchase Agreement with a
third party in the amount of $100,000. Under the term of the
agreement, the individual received 1,000,000 shares of subscribed common stock
of the Company at the rate of $0.10 per share and the right to purchase
1,000,000 warrants of the Company at the rate of $0.125 per
share. The warrants have a five year expiration date. From
the date of the agreement until the first anniversary of the agreement, in the
event that the Company issues or sells any shares of Common Stock or any Common
Stock Equivalents pursuant to which shares of Common Stock may be acquired at a
price less than $0.10 per share (a "Lower Price Issuance"), the purchaser shall
have the right to elect to substitute any term or terms of the offering being
made in connection with the Lower Price Issuance for any term of the offering in
connection with the Common Stock and Warrants (purchased hereunder) owned by the
subscriber.
On
February 1, 2010, the Company entered into a Debt Settlement Agreement with J.
Kellogg Parsons, M.D. the son of C. Lowell Parsons, M.D. a director of the
Company. Pursuant to the terms of the Debt Settlement Agreement, Dr. Parsons
converted outstanding unsecured promissory notes in the amount of $20,000 plus
accrued interest of $4,458 into 244,583 shares of subscribed common stock of the
Company at a rate of $0.10 per share.
20
ITEM
2: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OFOPERATIONS
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 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., Inc.
with Urigen N.A., Inc. 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. (the "Company").
From and
after the Merger, our business is conducted through our wholly owned subsidiary
Urigen N.A. The discussion of our business in this annual report is that of our
current business which is conducted through Urigen N.A.
We are
located in San Francisco, California, where our headquarters and business
operations are located.
BUSINESS
OVERVIEW
|
We
specialize in the development of innovative products for patients with
urological ailments including, specifically, the development of innovative
products for amelioration Painful Bladder Syndrome/Interstitial Cystitis (“PBS”
or “PBS/IC”), Urethritis, Nocturia 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 expectancy continues 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.
|
21
Urigen’s
two clinical stage products target significant unmet medical needs with
meaningful market opportunities in urology:
URG101, a
bladder instillation for Painful Bladder Syndrome/Interstitial Cystitis
(PBS/IC)
URG301, a
female urethral suppository for urethritis and nocturia
URG101
targets Painful Bladder Syndrome/Interstitial Cystitis (“PBS” or “PBS/IC”) which
affects approximately 10.5 million men and women in North
America. URG101 is a unique, proprietary combination therapy of
components that is locally delivered to the bladder for rapid relief of pain and
urgency as demonstrated in Urigen’s positive Phase II Pharmacodynamic Crossover
study.
URG301
targets urethritis and nocturia, typically seen in overactive bladder patients.
URG301 is a proprietary dosage form of an approved drug that is locally
delivered to the female urethra. Urethritis pain commonly occurs with urinary
tract infections (UTIs) which cause more than 8 million visits to the doctor
annually. Nocturia, or nighttime urgency and frequency, is secondary to
overactive bladder and can severely impact quality of life by disrupting the
normal sleep pattern.
The novel
urethral suppository platform presents excellent opportunities for effective
product lifecycle management. As market penetration of URG301
deepens, line extensions will be available through alternate generic drugs as
well as new chemical entities. To further expand the pipeline, the
Company will identify and prioritize both marketed and development-stage
products for acquisition. The commercial opportunity for such
candidates will benefit significantly from the synergy provided by URG101 and
URG301 in the urology marketplace.
We are
seeking a world wide partner for URG101 to complete it’s development and
commercialization. We had planned to market our products to urologists and
urogynecologists in the United States via a specialty sales force managed
internally.
Following
is a description of our products currently in development, the anticipated
market for such products as well as the competitive environment in these
markets.
URG101
Presently,
no approved products exist for treating PBS, and those that have been approved
for interstitial cystitis, a subset of PBS, are based on clinical studies which
have shown the drugs to be marginally effective. According to its website, the
FDA has approved two drugs for the treatment of interstitial cystitis and
neither is labeled as providing immediate system relief. For example, at three
months, the oral drug Elmiron achieved a therapeutic benefit in only 38% of
patients on active drug versus 18% on placebo. The other drug approved for
interstitial cystitis, RIMSO®-50 is an intravesical treatment that was not based
on double-blind clinical trial results. According to the Interstitial Cystitis
Data Base Study Experience published in the year 2000, RIMSO®-50 is widely
recognized as ineffective and not included among the top ten most common
physician-prescribed treatments for urinary symptoms.
Consequently,
there remains a significant need for new therapeutic interventions such as
URG101 that can address the underlying disease process while also providing
acute symptom relief. PBS is a chronic disease characterized by moderate to
severe pelvic pain, urgency, urinary frequency, dyspareunia (painful
intercourse) with symptoms originating from the bladder. Current epidemiology
data shows that PBS may be much more prevalent than previously
thought.
One
theory of PBS’s pathological cause implicates a dysfunction of the bladder
epithelium surface called the urothelium. Normally, the urothelium is covered
with a mucus layer, the glycosaminoglycan, or GAG, layer, which is thought to
protect the bladder from urinary toxins. A deficiency in the GAG layer would
allow these toxins to penetrate into the bladder wall activating pain sensing
nerves and causing bladder muscle spasms. These spasms trigger responses to
urinate resulting in the symptoms of pelvic pain, urgency and frequency, the
constellation of symptoms associated with this disease. Once established, PBS
can be a chronic disease, which can persist throughout life and can have a
devastating impact on quality of life.
In May of
2009, the RAND Corporation reported a survey of 100,000 households in the U.S.
and estimated that there are 3.4 to 7.9 million women in the U.S. with
interstitial cystitis. We had estimated that the prevalence of PBS in North
America to be 10.5 million, of which 3.8 million would experience severe enough
symptoms to be classified as having interstitial cystitis, a subset of PBS. This
estimate was based on studies conducted by Clemens and colleagues at
Northwestern University and by Drs. Matt T. Rosenberg and Matthew Hazzard
at the Mid-Michigan Health Centers. Each group independently concluded that the
number of subjects with interstitial cystitis has been significantly
underestimated. They evaluated over 1,000 female primary care patients over the
course of a year using a pain, urgency/frequency questionnaire to categorize
subjects as symptomatic or not. We calculated the North America PBS population
based on a cutoff score of 13 on the pain, urgency/frequency scale, and assumed
a ratio of 1:2 for men to women; and for interstitial cystitis population we
used a more stringent cutoff score of 15.
22
We have
licensed the URG101 technology from the University of California, San Diego. The
license agreement is exclusive with regard to patent rights and non-exclusive
with regard to the written technical information. We may also grant a sublicense
to third parties. Pursuant to the license agreement, which was effective as of
January 18, 2006, we were required to pay a license issue fee in the form
of 7.5% of Urigen N.A. authorized common stock, and we were required to pay
(i) license maintenance fees of $15,000 per year which was amended on
December 22, 2008 as follows: (a) $5,000 payable on May 6, 2009, (b) $15,000
payable on June 6, 2009, $20,000 payable on June 6, 2010 and $25,000 payable on
June 6, 2011 and annually thereafter on each anniversary until the Company is
commercially selling the licensed product. On August 24, 2009, the license
maintenance fees were amended again to provide (a) partial consideration
and in lieu of cash for license maintenance fees that were due on May 6, 2009
and June 6, 2009, and require the Company to issue 250,000 shares of
its common stock to the University, (b) $20,000 payable on June 6, 2010 and
$25,000 payable on June 6, 2011 and annually thereafter on each anniversary
until the Company is commercially selling the licensed product,
(ii) milestone payments of up to $625,000 upon the occurrence of certain
events related to FDA approval, (iii) an earned royalty fee equal to 1.5%
to 3.0% of net sales, (iv) sublicense fee, if applicable, and
(v) beginning in the year of any commercial sales, a minimum annual royalty
fee of $35,000. The term of the license agreement ends on the earlier of the
expiration date of the longest-lived 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, we may terminate the license
agreement at any time and for any reason upon a 90-day written notice. In the
event that any licensed product becomes the subject of a third-party claim, we
have the right to conduct the defense at our own expense, and may contest or
settle claims in our sole discretion; provided, however, that we may not agree
to any settlement that would invalidate any valid claim of the patent rights or
impose any ongoing obligation on the university. Pursuant to the terms of the
license agreement, we must indemnify the university against any and all claims
resulting or arising out of the exercise of the license or any sublicense,
including product liability. In addition, upon the occurrence of a sale of a
licensed product, application for regulatory approval or initiation of human
clinical trials, we must obtain and maintain comprehensive and commercial
general liability insurance.
The
individual components of this combination therapy, lidocaine and heparin, were
originally approved as a local anesthetic and an anti-coagulant, respectively.
It was demonstrated that a proprietary formulation of these components reduced
symptoms of pelvic pain and urgency upon instillation into the
bladder.
The
rationale for this combination therapy is two-fold. The lidocaine is a local
anesthetic that reduces the sensations of pain, urge and muscle spasms. The
heparin, a glycosaminoglycan, coats the bladder wall augmenting natural
heparinoids, which may be deficient on the surface of the urothelium. Heparin is
not being utilized in this application for its anti-coagulant properties.
Heparinoids comprise part of the mucus layer of the urothelium and help to limit
urinary toxins from penetrating the underlying tissues thereby preventing pain,
tissue inflammation and muscle spasms.
On
December 18, 2009, the Company entered into Consulting Agreement (the
“Agreement”) with Oceana Therapeutics, Inc. (“Oceana”). The Agreement provides
that Oceana will assist the Company in the development and preparation of a
Phase II meeting with the FDA in connection with URG-101. In addition, Oceana
agreed to pay the fees to the Company’s consultants in connection with the
meeting with the FDA in an amount of up to $50,000. In exchange for the services
to be rendered by Oceana, the Company agreed to provide to Oceana a right of
first refusal to license all indications of URG-101 that may be approved by the
FDA. The term of the Agreement commenced on December 18, 2009 and will continue
through that date that is 60 days after the Company’s meeting with the
FDA.
Clinical
Trial Status
Urigen
filed an investigational new drug application (“IND”) in 2005 and has undertaken
two (2) clinical studies to date: URG101-101 and URG101-104. The results of
the most recent study, URG101-104, have been announced with primary and
secondary endpoints all achieving statistical significance. The URG101-104 study
was designed using lessons learned from the URG101-101 study which did not
achieve statistical significance on the primary endpoint at 3 weeks, but did
demonstrate that the URG101 product was safe and resulted in an acute reduction
in urgency (P=0.006) and trend towards reduction in bladder pain
(P=0.093).
The
URG101-104 study was a pharmacodynamic crossover study to evaluate the time
course of response to URG101 drug and placebo in subjects experiencing acute
symptoms of painful bladder syndrome/interstitial cystitis. In March
2008 an un-blinded interim analysis was conducted. Primary and secondary
efficacy measurements in the study demonstrated that URG101 was significantly
better than placebo. Top line data analysis findings include: primary endpoint -
improvement in average daytime pain (p=0.03); secondary endpoints - improvement
in daytime urgency (p=0.03), total symptom score (p=0.03), improved overall
symptom relief as measured by PORIS (p=0.01).
Competitive
Landscape
PBS is
currently an underserved medical market. There is no acute treatment for pain of
bladder origin other than narcotics. Currently, there are two approved
therapeutics, RIMSO®-50 and Elmiron®, for the treatment of interstitial
cystitis. Both of these approved products require chronic administration before
any benefit is achieved. Other non-approved therapies provide marginal, if any
benefit.
Development
of drugs for PBS/IC has targeted a wide array of potential causes with limited
success. We believe that URG101 will be well positioned, as it will address both
the acute pain the patient experiences and the dysfunctional aspect of the
urothelium of the bladder wall.
23
Commercialization
Plan
Remaining
a virtual company, Urigen will commercialize URG101 in the United States by
collaborating with appropriate commercial partners and vendors to conduct a
situational analysis of the United States; develop an appropriate product
strategy; and then, create and implement a launch plan.
As
appropriate, co-promotional agreements will be established with interested
parties to ensure that URG101 is adequately promoted to the entire U.S.
healthcare community. In all countries outside the United States, Urigen will
either assign licensing rights to or establish Supply and Distribution
Agreements with interested parties. Initial discussions to acquire such rights
have begun with interested parties who have a strategic interest in Urology and
Painful Bladder Syndrome, and have the requisite infrastructure and resources to
successfully commercialize URG101.
Manufacturing
of URG101 finished goods kits will be conducted by contract manufacturers
approved by regulatory authorities and with a history of having demonstrated an
ability to support a global supply chain demand. Negotiations with such
manufacturers are in progress to establish requisite manufacturing and supply
agreements.
URG301
Market
Opportunity for Treatment of Urethritis and Nocturia
A
significant percentage of female patients presenting with Urinary Tract
Infections (UTI) and Painful Bladder Syndrome have a substantial urethral
component to their disease. There are approximately 8 million doctor visits
annually for urinary tract infections alone. The severity of their urethral pain
and discomfort may compromise the administration of intravesical therapies while
the antibiotics used to treat their UTI do not address their urethral pain. To
overcome this problem, Urigen is developing a urethral suppository to resolve
this pain and discomfort.
Nocturia,
frequent nighttime urination, is a symptom of an underlying condition or
disease, such as PBS. A poll conducted by the National Sleep
Foundation in 2003 reported that nearly two-thirds of adults between the ages of
55 and 84 suffered from nocturia. The International Continence
Society defines nocturia as two or more night time voids. In its
simplest terms, nocturia refers to urination at night and entails some degree of
impairment, with urinary frequency often considered excessive and
disruptive. Patients with severe nocturia may get up five or more
times per night to go to the bathroom to void.
Preliminary
work, by Kalium, Inc., from which we licensed the product, has been conducted to
test a variety of generally recognized as safe (“GRAS”) approved carriers and
therapeutic agents as well as to optimize melt times for the suppository.
Additionally, patients with urethritis were offered the use of a suppository
that contained lidocaine and heparin for the treatment of their symptoms of
urethral pain and inflammation. An optimized formulation has been tested in an
open-label clinical trial. This study was undertaken to determine the proportion
of urethral symptoms by 50% or more in patients with urethritis. Results were
evaluated 15 minutes after administration of the suppository using the patient
overall rating of improvement of symptoms (“PORIS”) scale. The result
of this pilot Phase II (open label) study in approximately 30 patients
demonstrated a 50% or greater improvement in 83% of patients experiencing pain
and 84% of patients experiencing urgency related to urethritis following a
single treatment. Importantly, 50% of patients had complete resolution of pain
and 63% had complete resolution of urgency. Duration of relief following a
single treatment was greater than 12 hours in approximately 30% of subjects.
This testing was not performed as a formal clinical trial, but under physician
care and information provided to us from Kalium, Inc. Clinical development of
URG301 will be similar to that of lidocaine jelly which is approved for
urethritis.
The
licensed patents cover a range of active ingredients that can be formulated in
the suppository to create a desired therapeutic effect. Such agent may include
antibiotics, antimicrobials, antifungals, analgesics, anesthetics, steroidal
anti-inflammatories, non-steroidal anti-inflammatories, mucous production
inhibitors, hormones and antispasmodics.
Market
Opportunity for Treatment of Overactive Bladder (“OAB”)
According
to an article published by the Mayo Foundation for Medical Education and
Research, overactive bladder is a fairly common malady as approximately 17
million individuals in the United States and more than 100 million worldwide are
afflicted. Importantly, the condition worsens as people age.
Although
not life-threatening, for the individual overactive bladder is inconvenient,
potentially embarrassing, and may disrupt sleep; while significantly impacting
quality of life. Frequently these individuals are afraid to leave their home, or
are unable to participate in a lengthy meeting, dinner, or social event.
Unfortunately, many of these people hesitate to seek treatment because they
think their symptoms are a normal part of aging. This mindset is incorrect as
overactive bladder is not normal, is treatable, and treatment can significantly
ease symptoms and improve quality of life.
Patient
compliance studies report that more than half of patients taking an oral OAB
drug stop taking it within six months of initiation of therapy. Such studies
also report that only 10 to 20 percent of people remain on an oral OAB medicine
six to 12 months after initiating treatment. About a third to one-half of those
who discontinue their drug therapy do so due to side effects, they simply can
not tolerate the drug or do not find the minimal benefit they receive to
outweigh the negative effects of the drug.
24
Manufacturers
of these overactive bladder therapies have expended significant research energy
and money in their efforts to reduce side effects to increase patients’
adherence to treatment. However, some physicians, experts and healthcare
providers do not believe that the marginal benefits of these oral agents
outweigh the significant side effects endured by patients prescribed such
drugs.
Importantly,
given these efficacy and side effect limitations, the overactive bladder market
has experienced significant and constant
double
digit annual growth. According to sales data provided by the four largest U.S.
pharmaceutical companies in their annual reports, we estimate that in the five
year period 2000 through 2004, sales of OAB drugs in the United States grew from
$636 million to more than $1.3 billion, and year over year percentage increases
for this five year period were 40%, 25%, 18%, and 13%,
respectively.
Product
Development
We are
developing an IND to initiate an exploratory study to evaluate the safety and
efficacy of an intraurethral suppository to treat urethritis, nocturia and the
symptoms of acute urinary urgency associated with overactive bladder. The study
will enroll subjects randomized to drug vs. placebo in a 1:1 ratio to evaluate
the safety and efficacy of URG301 for one or more of these
disorders.
Commercialization
Plan
Although
we are seeking a world wide partner for URG101, we will commercialize URG301 in
the United States by conducting a situational analysis of the United States;
developing an appropriate product strategy; and then, creating and implementing
a launch plan that incorporates the 75 to 100 member sales organization that we
are planning to establish for the launch of URG101. As appropriate,
co-promotional agreements will be established with interested parties to ensure
that URG301 is adequately promoted to the entire U.S. healthcare
community.
In all
countries outside the United States, Urigen will either assign licensing rights
to or establish Supply and Distribution Agreements with interested parties.
Discussions to acquire such rights will be scheduled with interested
pharmaceutical companies who have a strategic interest in Incontinence and
Overactive Bladder, and have the requisite infrastructure and resources to
successfully commercialize URG301.
Competitive
Landscape
Approved
prescription drugs used to treat overactive bladder are not optimally effective
and have side effects that can limit their use. These approved drugs—oxybutynin
(Ditropan®, Ditropan XL® and Oxytrol®, a skin patch); tolterodine (Detrol®,
Detrol LA®); trospium (Sanctura®); solifenacin (Vesicare®); and darifenacin
(Enablex®)—demonstrate remarkably similar efficacy.
However,
they do differ in the side effects they cause and their cost. Side effects
include dry mouth, constipation, and mental confusion. In clinical studies,
Ditropan XL, Detrol LA, Oxytrol, Sanctura, Vesicare, and Enablex have caused
fewer side effects than the short acting dosage forms of oxybutynin (Ditropan)
and tolterodine (Detrol).
Oxybutynin
has been available since 1976 and tolterodine since 1998. The short-acting form
of oxybutynin is available as a less expensive generic drug while the
extended-release formulations of both oxybutynin and tolterodine are available,
but not as generics. An oxybutynin patch (Oxytrol) was launched in 2003 while
solifenacin and darifenacin were introduced in 2004.
Retail
prices for these products vary considerably and are tied directly to the number
of pills taken per day and whether or not the product is available generically.
The least expensive is generic oxybutynin 5mg with an average monthly cost of
$20 compared to Ditropan 5mg at $79 and Ditropan XL 5mg costing $122 per month
on average. The average monthly cost for Detrol is $138; Detrol LA $119;
Sanctura $116; Vesicare $121; and Enablex $116. (Prices from May 2006
Wolters Kluwer Health, Pharmaceutical Audit Suite).
We
retained Navigant Consulting, Inc. to conduct a situational assessment of
physicians, healthcare payers and patient advocacy groups to generate a product
strategy that addressed key geographical markets, customers, product
positioning, lifecycle management and pricing. The project cost of this first
phase was $125,000, of which $86,000 had been paid through December 31,
2009.
Life
Science Strategy Group LLC (LSSG) was retained to create and implement a
commercialization plan specific for us in the United States. Pursuant to the
terms of the agreement, LSSG billed us for all professional services at
established hourly rates, plus related out-of-pocket expenses. Payment of
invoices is not contingent upon results. LSSG may terminate the agreement if
payment of fees is not made within 45 days of receipt of the invoice. There is
no definitive termination date of the agreement, but the estimated timing for
all of the projects ranges from 30 to 42 months. As appropriate,
co-promotional agreements will be established with interested parties to ensure
that URG101 is adequately promoted to the entire United States healthcare
community. As of September 30, 2009 LSSG had invoiced the Company
$28,000 of which $3,000 was paid in cash. LSSG principals
agreed to accept 147,059 shares of subscribed common stock at $0.17 per share in
lieu of the remaining $25,000.
We also
have two license agreements pursuant to which we license certain patent rights
and technologies:
25
In
January 2006, Urigen N.A. entered into an asset-based transaction
agreement with a related party, Urigen, Inc. Simultaneously, Urigen
N.A. entered into a license agreement with the University of California,
San Diego (“UCSD”), for certain patent rights. In exchange for this
license, Urigen N.A. issued 1,846,400 common shares and is required to make
annual maintenance payments of $15,000 which was amended on December 22, 2008 as
follows: (a) $5,000 payable on May 6, 2009, (b) $15,000 payable on June 6, 2009,
(c) $20,000 payable on June 6, 2010 and (d) $25,000 payable on June 6, 2011 and
annually thereafter on each anniversary until the Company is commercially
selling the licensed product, and milestone payments of up to $625,000, which
are based on certain events related to FDA approval. On August 24, 2009, the
license maintenance fees were amended to provide partial consideration and in
lieu of cash for license maintenance fees that were due on May 6, 2009 and June
6, 2009, and required the Company to issue 250,000 shares of its common
stock to the UCSD. All remaining annual maintenance fees remain the same. Urigen
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 of the patents 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.
Pursuant
to our license agreement with Kalium, Inc., made as of May 12, 2006, the
Company and our affiliates have an exclusive license to the patent rights
and technologies, and the right to sublicense to third parties. As partial
consideration for the rights under the license agreement and as a license fee,
Urigen N.A., Inc. was required to issue 1,623,910 shares of our common
stock. We are required to pay royalties ranging from 2.0% to 4.5% of net sales,
and milestone payments of up to $457,500 upon the occurrence of certain events
related to FDA approval, and any applicable sublicense payments in an amount
equal to 22.5% of fees received for any sublicense. Pursuant to the terms of the
license agreement, we must indemnify Kalium against any and all liabilities or
damages arising out of the development or use of the licensed products or
technology, the use by third parties of licensed products or technology, or any
representations or warranty by us. In the event that any licensed product
becomes the subject of a third-party claim, we have the right to conduct the
defense at our own expense, and may settle claims in our sole discretion;
provided, however, that Kalium must cooperate with us. The term of the license
agreement ends on the earlier of the expiration date of the last to expire of
any patent or the tenth anniversary of the first commercial sale. The license
agreement may be terminated by either party if the other party fails to
substantially perform or otherwise materially breaches any material terms or
covenants of the agreement, and such failure or breach is not cured within
30 days of notice thereof. In addition, Kalium may terminate the agreement
or convert the license to non-exclusive rights if we fail to meet certain
milestones over the next three years. On November 10, 2008, Kalium
amendment the May 2006 license agreement extending the time period from three
years to four years for the time period to complete a clinical trial or license
the product in a territory.
In
countries outside of the United States, we anticipate we will either assign
licensing rights to or establish supply and distribution agreements with
interested parties. Initial discussions to acquire such rights have begun with
interested parties who have a strategic interest in urology and painful bladder
syndrome and have the requisite infrastructure and resources to successfully
commercialize URG101.
Like many
companies our size, we do not have the ability to conduct preclinical or
clinical studies for our product candidates without the assistance of third
parties who conduct the studies on our behalf. These third parties are usually
toxicology facilities and clinical research organizations (“CROs”) that have
significant resources and experience in the conduct of pre-clinical and clinical
studies. The toxicology facilities conduct the pre-clinical safety studies as
well as all associated tasks connected with these studies. The CROs typically
perform patient recruitment, project management, data management, statistical
analysis, and other reporting functions.
Third
parties that we use, and have used in the past, to support clinical trials
include Clinimetrics, Research Canada, Inc., EMB Statistical Solutions, LLC
(“EMB”), and Hyaluron. Inc. (“HCM”).
Pursuant
to a purchase order dated September 2007, HCM has provided us with services
related to documentation and drug development. Various services were
provided by the other vendors listed.
We intend
to continue to rely on third parties to conduct clinical trials of our product
candidates and to use different toxicology facilities and CROs for all of our
pre-clinical and clinical studies.
On
December 18, 2009, the Company entered into Consulting Agreement (the
“Agreement”) with Oceana Therapeutics, Inc. (“Oceana”). The Agreement provides
that Oceana will assist the Company in the development and preparation of a
Phase II meeting with the FDA in connection with URG-101. In addition, Oceana
agreed to pay the fees to the Company’s consultants in connection with the
meeting with the FDA in an amount of up to $50,000. In exchange for the services
to be rendered by Oceana, the Company agreed to provide to Oceana a right of
first refusal to license all indications of URG-101 that may be approved by the
FDA. The term of the Agreement commenced on December 18, 2009 and will continue
through that date that is 60 days after the Company’s meeting with the
FDA.
We have
multiple intellectual property filings around our products. In general, we plan
to file for broad patent protection in all markets where we intend to
commercialize our products. Typically, we will file our patents first in the
United States or Canada and expand the applications internationally under the
Patent Cooperation Treaty, or PCT.
26
Currently,
we own or have licensed three (3) issued patents and three (3) patent
applications. Based on these filings, we anticipate that our lead product
URG101, may be protected until at least 2026 and our URG300 urethral suppository
platform including URG301 will be protected until at least 2018 and potentially
beyond 2025.
Summary
of our Patents and Patent Applications for URG101 and URG301 Product
Development:
1.
|
(URG101)
We have licensed U.S.
Patent 7,414,039 entitled “Novel Interstitial Therapy for Immediate
Symptom Relief and Chronic Therapy in Interstitial Cystitis” from the
University of California San Diego. The patent claims treatment
formulations and methods for reducing the symptoms of urinary frequency,
urgency and/or pelvic pain, including interstitial
cystitis.
|
2.
|
(URG101)
We have filed PCT Application PCT/US2006/019745 entitled “Kits and
Improved Compositions for Treating Lower Urinary Tract Disorders:
Formulations for Treating Lower Urinary Tract Symptoms: which is directed
to superior buffered formulations and kits for treating lower urinary
tract symptoms and disorders.
|
3.
|
(URG301)
We have licensed U.S.
Patent No. 6,464,670 entitled “Method of Delivering Therapeutic
Agents to the Urethra and an Urethral Suppository” from Kalium, Inc.
The patent describes a meltable suppository having a “baseball bat” shape
for the administration of therapeutic agents to the urethra. This shape is
suited for the female urethra.
|
4.
|
(URG301)
We have licensed U.S.
Patent No. 7,267,670 entitled “Reinforced Urethral Suppository”
from Kalium, Inc. This application covers the mechanical structure of
a reinforced suppository that can be used to deliver a range of
therapeutic agents to the urethra.
|
5.
|
(URG301)We
have licensed U.S.
Patent Application Serial No. 11/475809, entitled
“Transluminal Drug Delivery Methods and Devices” from Kalium, Inc.
The application is directed to a urethral suppository that includes a
carrier base, an anesthetic, a buffering agent, and, optionally a
polysaccharide.
|
6.
|
(URG301)
We have filed PCT Application 60/891,454 entitled "Urethral Suppositories
for Overactive Bladder" which is directed to the use of mixed-activity
anti-cholinergic agents to treat the symptoms of overactive
bladder.
|
Our
failure to obtain patent protection or otherwise protect our proprietary
technology or proposed products may have a material adverse effect on our
competitive position and business prospects. The patent application process
takes several years and entails considerable expense. There is no assurance that
additional patents will issue from these applications or, if patents do issue,
that the claims allowed will be sufficient to protect our
technology.
The
patent positions of pharmaceutical and biotechnology firms are often uncertain
and involve complex legal and factual questions. Furthermore, the breadth of
claims allowed in biotechnology patents is unpredictable. We cannot be certain
that others have not filed patent applications for technology covered by our
pending applications or that we were the first to invent the technology that is
the subject of such patent applications. Competitors may have filed applications
for, or may have received patents and may obtain additional patents and
proprietary rights relating to compounds, products or processes that block or
compete with ours. We are aware of patent applications filed and patents issued
to third parties relating to urological drugs, urological delivery technologies
and urological therapeutics, and there can be no assurance that any of those
patent applications or patents will not have a material adverse effect on
potential products we or our corporate partners are developing or may seek to
develop in the future.
Patent
litigation is widespread in the biotechnology industry. Litigation may be
necessary to defend against or assert claims of infringement, to enforce patents
issued to us, to protect trade secrets or know-how owned or licensed by us, or
to determine the scope and validity of the proprietary rights of third parties.
Although no third party has asserted that we are infringing such third party’s
patent rights or other intellectual property, there can be no assurance that
litigation asserting such claims will not be initiated, that we would prevail in
any such litigation or that we would be able to obtain any necessary licenses on
reasonable terms, if at all. Any such claims against us, with or without merit,
as well as claims initiated by us against third parties, can be time-consuming
and expensive to defend or prosecute and to resolve. If other companies prepare
and file patent applications in the United States that claim technology also
claimed by us, we may have to participate in interference proceedings to
determine priority of invention which could result in substantial cost to us
even if the outcome is favorable to us. There can be no assurance that third
parties will not independently develop equivalent proprietary information or
techniques, will not gain access to our trade secrets or disclose such
technology to the public or that we can maintain and protect unpatented
proprietary technology. We typically require our employees, consultants,
collaborators, advisors and corporate partners to execute confidentiality
agreements upon commencement of employment or other relationships with us. There
can be no assurance, however, that these agreements will provide meaningful
protection or adequate remedies for our technology in the event of unauthorized
use or disclosure of such information, that the parties to such agreements will
not breach such agreements or that our trade secrets will not otherwise become
known or be discovered independently by our competitors.
27
GOVERNMENT
REGULATION
The
production and marketing of any of our potential products will be subject to
extensive regulation for safety, efficacy and quality by numerous governmental
authorities in the United States and other countries. In the United States,
pharmaceutical products are subject to rigorous regulation by the United States
Food and Drug Administration (“FDA”). We believe that the FDA and comparable
foreign regulatory bodies will regulate the commercial uses of our potential
products as drugs. Drugs are regulated under certain provisions of the Public
Health Service Act and the Federal Food, Drug, and Cosmetic Act. These laws and
the related regulations govern, among other things, the testing, manufacturing,
safety, efficacy, labeling, storage, record keeping, and the promotion,
marketing and distribution of drug products. At the FDA, the Center for Drug
Evaluation and Research is responsible for the regulation of drug
products.
The
necessary steps to take before a new drug may be marketed in the United States
include the following: (i) laboratory tests and animal studies;
(ii) the submission to the FDA of an IND for clinical testing, which must
become effective before clinical trials commence; (iii) under certain
circumstances, approval by a special advisory committee convened to review
clinical trial protocols involving drug therapeutics; (iv) adequate and
well-controlled clinical trials to establish the safety and efficacy of the
product; (v) the submission to the FDA of a new drug application (“NDA”);
and (vi) FDA approval of the new drug application prior to any commercial
sale or shipment of the drug.
Facilities
used for the manufacture of drugs are subject to periodic inspection by the FDA
and other authorities, where applicable, and must comply with the FDA’s Good
Manufacturing Practice (“GMP”), regulations. Manufacturers of drugs also must
comply with the FDA’s general drug product standards and may also be subject to
state regulation. Failure to comply with GMP or other applicable regulatory
requirements may result in withdrawal of marketing approval, criminal
prosecution, civil penalties, recall or seizure of products, warning letters,
total or partial suspension of production, suspension of clinical trials, FDA
refusal to review pending marketing approval applications or supplements to
approved applications, or injunctions, as well as other legal or regulatory
action against us or our corporate partners.
Clinical
trials are conducted in three sequential phases, but the phases may overlap. In
Phase I (the initial introduction of the product into human subjects or
patients), the drug is tested to assess safety, metabolism, pharmacokinetics and
pharmacological actions associated with increasing doses. Phase II usually
involves studies in a limited patient population to (i) determine the
efficacy of the potential product for specific, targeted indications,
(ii) determine dosage tolerance and optimal dosage, and (iii) further
identify possible adverse effects and safety risks. If a compound is found to be
effective and to have an acceptable safety profile in Phase II evaluations,
Phase III trials are undertaken to further evaluate clinical efficacy and
test for safety within a broader patient population at geographically dispersed
clinical sites. There can be no assurance that Phase I, Phase II or
Phase III testing will be completed successfully within any specific time
period, if at all, with respect to any of our or our corporate partners’
potential products subject to such testing. In addition, after marketing
approval is granted, the FDA may require post-marketing clinical studies that
typically entail extensive patient monitoring and may result in restricted
marketing of the product for an extended period of time.
The
results of product development, preclinical animal studies, and human studies
are submitted to the FDA as part of the NDA. The NDA must also contain extensive
manufacturing information, and each manufacturing facility must be inspected and
approved by the FDA before the NDA will be approved. Similar regulatory approval
requirements exist for the marketing of drug products outside the
United States (e.g., Europe and Japan). The testing and approval process is
likely to require substantial time, effort and financial and human resources,
and there can be no assurance that any approval will be granted on a timely
basis, if at all, or that any potential product developed by us and/or our
corporate partners will prove safe and effective in clinical trials or will meet
all the applicable regulatory requirements necessary to receive marketing
approval from the FDA or the comparable regulatory body of other countries. Data
obtained from preclinical studies and clinical trials are subject to
interpretations that could delay, limit or prevent regulatory approval. The FDA
may deny the NDA if applicable regulatory criteria are not satisfied, require
additional testing or information, or require post-marketing testing and
surveillance to monitor the safety or efficacy of a product. Moreover, if
regulatory approval of a biological product candidate is granted, such approval
may entail limitations on the indicated uses for which it may be marketed.
Finally, product approvals may be withdrawn if compliance with regulatory
standards is not maintained or if problems occur following initial marketing.
Among the conditions for NDA approval is the requirement that the prospective
manufacturer’s quality control and manufacturing procedures conform to the
appropriate GMP regulations, which must be followed at all times. In complying
with standards set forth in these regulations, manufacturers must continue to
expend time, financial resources and effort in the area of production and
quality control to ensure full compliance.
For
clinical investigation and marketing outside the United States, we and our
corporate partners may be subject to FDA as well as regulatory requirements of
other countries. The FDA regulates the export of drug products, whether for
clinical investigation or commercial sale. In Europe, the approval process for
the commencement of clinical trials varies from country to country. The
regulatory approval process in other countries includes requirements similar to
those associated with FDA approval set forth above. Approval by the FDA does not
ensure approval by the regulatory authorities of other countries.
GENERAL
COMPETITION WITHIN THE UROLOGICAL THERAPEUTIC INDUSTRY
Competition
in the pharmaceutical industry is intense and is characterized by extensive
research efforts and rapid technological progress. Several pharmaceutical
companies are also actively engaged in the development of therapies for the
treatment of PBS and overactive bladder. Such competitors may develop
safer, more effective or less costly urological therapeutics. We face
competition from such companies, in establishing corporate collaborations with
pharmaceutical and biotechnology companies, relationships with academic and
research institutions and in negotiating licenses to proprietary technology,
including intellectual property.
28
Many
competitors and potential competitors have substantially greater product
development capabilities and financial, scientific, manufacturing, managerial
and human resources than we do. There is no assurance that research and
development by such competitors will not render our potential products and
technologies, or the potential products and technologies developed by our
corporate partners, obsolete or non-competitive, or that any potential product
and technologies us or our corporate partners develop would be preferred to any
existing or newly developed products and technologies. In addition, there is no
assurance that competitors will not develop safer, more effective or less costly
PBS therapies, achieve superior patent protection or obtain regulatory
approval or product commercialization earlier than us or our corporate partners,
any of which could have a material adverse effect on our business, financial
condition or results of operations.
PRODUCT
LIABILITY INSURANCE
The
manufacture and sale of human therapeutic products involve an inherent risk of
product liability claims and associated adverse publicity. We currently do not
have product liability insurance, and there can be no assurance that we will be
able to obtain additional product liability insurance on acceptable terms or
with adequate coverage against potential liabilities. Such insurance is
expensive, difficult to obtain and may not be available in the future on
acceptable terms, or at all. An inability to obtain sufficient insurance
coverage on reasonable terms or to otherwise protect against potential product
liability claims could inhibit our business. A product liability claim brought
against us, if any, could have a material adverse effect upon our business,
financial condition and results of operations.
EMPLOYEES
We
currently employ two individuals full-time, including one who holds a doctoral
degree. Current employees are engaged in product development, marketing, finance
and administrative activities, including assessing strategic opportunities that
may be available to us. Our employees are not represented by a collective
bargaining agreement.
CRITICAL
ACCOUNTING POLICIES
There
were no significant changes in our critical accounting policies during the six
months ended December 31, 2009 as compared to what was previously disclosed in
our Annual Report on Form 10-K for the year ended June 30, 2009 filed with the
Securities and Exchange Commission (the “SEC”) on September 24,
2009.
Recent
Accounting Pronouncements
Information
with respect to Recent Accounting Pronouncements may be found in Note 2 to the
Notes of Unaudited Condensed Consolidated Financial Statements in “Part I.
Financial Information – Item 1. Financial Statements” of this Quarterly Report
on Form 10-Q.
RESULTS
OF OPERATIONS
Overview
For the
three month period ended December 31, 2009, net loss has increased by
$576,992 to $1,007,964 as compared to net loss of $430,972 for the corresponding
period in 2008. This increase was due primarily to more non-cash
mark-to-market expense compared to 2008 quarter, offset by decreased expenses in
sales and marketing, general and administrative and research and
development.
For the
six month period ended December 31, 2009, net loss has increased by $63,514 to
$956,482, as compared to a net loss of $892,968 for the corresponding period in
2008. This increase was due primarily to increased mark-to-market
expense offset by decreased expenses in sales and marketing, general and
administrative and research and development.
At
December 31, 2009, our accumulated deficit was $12,956,312. 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.
Revenue
There
were no revenues for the three and six month periods ended December 31, 2009 and
2008.
Research
and Development Expenses
Research
and development expenses decreased $55,567 to $3,532 for the three months ended
December 31, 2009 from $59,099 for the corresponding period in 2008. This
decrease was due to reduced clinical trial expenses and the reduction in
staff.
Research
and development expenses decreased $142,820 to $10,982 for the six months ended
December 31, 2009 from $153,802 for the corresponding period in
2008. This decrease was due to reduced clinical trial expenses in the
current fiscal year and the reduction in staff. 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, if the
Company’s liquidity improves.
29
General
and Administrative Expenses
General
and administrative expenses decreased $117,933 to $239,111 for the three months
ended December 31, 2009, compared to $357,044 for the corresponding period in
2008. The decrease in general and administrative expenses was due to a reduction
in staff, accounting and board of director fees offset by an increase in legal
fees.
General
and administrative expenses decreased $155,437 to $586,881 for the six months
ended December 31, 2009, compared to $742,318 for the corresponding period in
2008. The decrease in general and administrative expenses was due to
a reduction in staff, accounting and board of directors fees and rent offset by
an increase in legal fees. We expect general and administrative
expenses to increase going forward if the Company’s liquidity
improves.
Sales
and Marketing Expenses
Sales and
marketing expenses decreased $38,197 to $0 for the three months ended December
31, 2009, compared to $38,197 for the corresponding period in 2008. The decrease
was due to no sales and marketing activity in the current period.
Sales and
marketing expenses decreased $88,680 to $0 for the six months ended December 31,
2009, compared to $88,680 for the corresponding period in 2008. The
decrease was due to no sales and marketing activity in the current fiscal
year. We expect sales and marketing expenses to increase going
forward as we proceed to move our technologies forward towards
commercialization, if the Company’s liquidity improves.
Interest
Income and Other Income and Expenses, net
Interest
income and other income and expenses, net, changed by $755,418 to $701,065 of
expense for the three months ended December 31, 2009, compared to $54,353
of income in the corresponding period of 2008. The change was due to
a larger mark-to-market impact on the Company’s Series B Preferred Stock and
Warrants classified as debt during the three month period ending December 31,
2009.
Interest
income and other income and expenses, net, changed by $383,558 to $222,571 of
expense for the six months ended December 31, 2009, compared to $160,987 of
income in the corresponding period of 2008. The change was due to a
larger mark-to-market impact on the Company’s Series B Preferred Stock and
Warrants classified as debt during the six month period ending December 31,
2009.
Interest
Expense
Interest
expense increased by $33,271 to $64,256 for the three months ended December 31,
2009, compared to $30,985 in the corresponding period of 2008. The
increase was primarily due to interest expense on additional secured and
unsecured notes payable financing.
Interest
expense increased by $66,893 to $136,048 for the six months ended December 31,
2009, compared to $69,155 in the corresponding period of 2008. The
increase was primarily due to interest expense on additional secured and
unsecured notes payable financing.
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, 2009, 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 identified the following conditions
which raise substantial doubt about our ability to continue as a going concern,
and such conditions include: (i) we have incurred operating
losses since inception, including a net loss of $2,256,607 for the fiscal year
ended June 30, 2009, and net loss for the six months ended December
31, 2009 of $956,482, an accumulated deficit of $12,956,312 at December
31, 2009 and a working capital deficit of $6,486,159 at December 31, 2009,
and (ii) we anticipate to incur further losses for the foreseeable
future. We expect 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 our
operations.
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.
30
Net cash
used in operating activities for the six months ended December 31, 2009 was
$327,904, which primarily reflected the net loss of $956,482, adjusted for
increases in payables of $95,788 and accrued expenses of $269,593, non-cash
expenses of $65,978, as well as a change in the fair value of the Series B
convertible preferred stock and warrant liabilities of $216,163. Net cash used
in operating activities for the six months ended December 31, 2008 was
$251,295 which primarily reflected the net loss of $892,968, adjusted for
increases in payables of $114,553 and accrued expenses of $562,472.
There
were no significant investing activities for the six months ended December
31, 2009 or 2008.
For the
six months ended December 31, 2009, net cash provided by financing
activities was $325,500, which was primarily due to the issuance of notes
payable in the amount of $290,500. For the six months ended December
31, 2008, net cash provided by financing activities was $205,000, which
reflected $205,000 for the issuance of notes payable.
On
October 26, 2009, the Company entered into Debt Settlement Agreements with
William J. Garner, its CEO, and KTEC Holdings, Inc. (“KTEC”). Pursuant to the
terms of the Debt Settlement Agreements, Dr. Garner converted outstanding
unsecured promissory notes in the amount of $25,000 plus accrued interest of
$4,256 into 292,562 shares of subscribed common stock of the
Company. KTEC converted an outstanding unsecured promissory note of
$100,000 plus accrued interest of $28,444 into 1,284,441 shares of subscribed
common stock of the Company. All of the shares were converted at a
rate of $0.10 per share.
On
October 27, 2009, the Company entered into a Debt Settlement Agreement with C.
Lowell Parsons, a director of the Company. Pursuant to the terms of the Debt
Settlement Agreement, Dr. Parsons converted outstanding unsecured promissory
notes in the amount of $412,000 plus accrued interest of $76,886 into 4,888,862
shares of subscribed common stock of the Company at a rate of $0.10 per
share.
On
December 29, 2009, the Company entered into a Debt Settlement Agreement with the
Catalyst Law Group APC (“Catalyst Group”). Pursuant to the terms of the Debt
Settlement Agreement, the Catalyst Group agreed to convert the outstanding
amount of $121,342, including accrued interest, owed by the Company into
1,213,419 shares subscribed common stock at a rate of $0.10 per
share.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Urigen’s
exposure to market risk for changes in interest rates relates primarily to our
cash balances. 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 cash balances as of December 31, 2009.
December
31,
|
||||
2009
|
||||
Cash
|
$ | 401 | ||
Average
interest rate
|
0.07 | % |
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. Disclosure controls and
procedures, include, without limitation, controls and procedures designed to
ensure that information required to be disclose in the reports that it files or
submits is accumulated and communicated to the company’s management, including
its principal executive and principal financial officers, or persons performing
similar functions, as appropriate to allow timely decisions regarding required
disclosures. 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.
Changes in Internal Control Over
Financial Reporting. During the most recent quarter ended December 31,
2009, there has been no change in our internal control over financial reporting
(as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act)) that has
materially affected, or is reasonably likely to materially affect, our internal
control over financial reporting.
In
connection with its audit of our consolidated financial statements for the year
ended June 30, 2009, our independent registered accounting firm identified
significant deficiencies in our internal controls, which represent material
weaknesses.
Management
noted an insufficient quantity of experienced, dedicated resources
involved in control activities and
financial
reporting. This material weakness contributed to a control environment
where there is a reasonable
possibility
that a material misstatement of the interim and annual financial
statements could occur and not be
prevented
or detected on a timely basis.
|
The
Company’s design and operation of controls with respect to the process of
preparing and reviewing the annual and interim financial statements are
ineffective. This material weakness includes failures in the design and
operating effectiveness of controls which would insure (i) preparation of
financial statements and disclosures on a timely basis; (ii) that all journal
entries and financial disclosures are thoroughly reviewed and approved
internally and documentation of this review process is retained; (iii) adequate
separation of duties in the reporting process, and (iv) timely reconciliation of
balance sheet and expense accounts. These control deficiencies could
result in a material misstatement of the financial statements due to the
significance of the financial closing and reporting process to the preparation
of reliable financial statements.
31
Prior to
the issuance of our condensed consolidated financial statements, we completed
the needed analyses and our management review such that we can certify that the
information contained in our condensed consolidated financial statements
included in this quarterly report, 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 controls. 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.
ITEM
1. LEGAL PROCEEDINGS
In
December 2009, a Complaint was filed against the Company by Artizen,
Inc. in Superior Court, San Francisco County to recover $53,465 together with
interest at the rate of 7% per annum from October 7, 2007 for services rendered
to the Company. The Company’s records indicate that Artizen, Inc. is
owed $46,242 and has requested documentation of the amount alleged in the
complaint. On
October 14, 2009, the Company had previously offered to settle this debt through
the issuance of the Company’s restricted common stock, but the offer was not
accepted. A case management conference has been scheduled for April
16, 2010 in this matter.
ITEM
1A. RISK FACTORS
There are
no material changes from the risk factors previously disclosed in our Form I0-K
for the year ended June 30, 2009 filed with the SEC on September 24,
2009.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
On
October 26, 2009, the Company issued 250,000 shares of common stock to the
Regents of the University of California (“University”) pursuant to the terms of
an amendment to the license maintenance fees to the University.
On
October 26, 2009, the Company issued 292,562 shares of subscribed common stock
to William J. Garner, CEO, pursuant to a Debt Settlement Agreement at $0.10 per
share.
On
October 26, 2009, the Company issued 4,888,862 shares of subscribed common stock
to C. Lowell Parsons, a director of the Company, pursuant to a Debt Settlement
Agreement at $0.10 per share.
On November 4, 2009, the Company
issued 100,000 shares of subscribed common stock to a third party at $0.10 per
share.
On
November 6, 2009, the Company issued 1,248,441 shares of subscribed common stock
to KTEC Holdings, Inc. pursuant to a Debt Settlement Agreement at $0.10 per
share.
On
November 9, 2009, the Company issued 250,000 shares of subscribed common stock
to a third party at $0.10 per share.
On
December 29, 2009, the Company entered into a Debt Settlement Agreement with the
Catalyst Law Group APC (“Catalyst Group”). Pursuant to the terms of the Debt
Settlement Agreement, the Catalyst Group agreed to convert the outstanding
amount of $121,342, including accrued interest, owed by the Company into
1,213,419 shares subscribed common stock at a rate of $0.10 per
share.
We
believe that the issuance of the securities referenced were exempt from
registration under the Securities Act of 1933, as amended (the “Securities Act”)
by virtue of Section 4(2) of the Securities Act and/or Regulation D
promulgated thereunder as transactions not involving any public
offering.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM
4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None.
ITEM
5. OTHER INFORMATION
None.
32
ITEM
6. EXHIBITS
a. Exhibits
31.1
|
Certification
of Principal Executive Officer and Principal Financial and Accounting
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*
|
* Filed herewith
33
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
URIGEN
PHARMACEUTICALS, INC.
|
|||
February
16, 2010
|
By:
|
/s/ William
J. Garner, MD
|
|
WILLIAM
J. GARNER, MD
|
|||
President
and Chief Executive Officer
|
|||
(Principal
Executive Officer and Principal Financial and Accounting
Officer)
|
34