Oncotelic Therapeutics, Inc. - Quarter Report: 2008 September (Form 10-Q)
Table of Contents
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2008
OR
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number: 0-21990
OXiGENE, INC.
(Exact name of registrant as specified in its charter)
Delaware | 13-3679168 | |
(State or other jurisdiction of | (I.R.S. Employer | |
incorporation or organization) | Identification No.) |
230 THIRD AVENUE
WALTHAM, MA 02451
(Address of principal executive offices, including zip code)
(781) 547-5900
(Registrants telephone number, including area code)
Not applicable
(Former name, former address and former fiscal year, if changed since last report)
WALTHAM, MA 02451
(Address of principal executive offices, including zip code)
(781) 547-5900
(Registrants telephone number, including area code)
Not applicable
(Former name, former address and former fiscal year, if changed since last report)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
(Check one):
Large accelerated filer o | Accelerated filer þ | Non-accelerated filer o | Smaller reporting company o | |||
(Do not check if a smaller reporting company) |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes o No þ
As of October 17, 2008, there were 35,011,448 shares of the Registrants Common Stock issued and
outstanding.
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OXiGENE, INC.
Cautionary Factors that May Affect Future Results
Cautionary Factors that May Affect Future Results
The disclosure and analysis by OXiGENE, Inc. (the Company) in this report contain
forward-looking statements. Forward-looking statements give managements current expectations or
forecasts of future events. You can identify these statements by the fact that they do not relate
strictly to historic or current facts. They use words, such as anticipate, estimate, expect,
project, intend, plan, believe, and other words and terms of similar meaning. These include
statements, among others, relating to our planned future actions, our clinical trial plans, our
research and development plans, our prospective products or product approvals, our beliefs with
respect to the sufficiency of our financial resources, our plans with respect to funding
operations, projected expense levels, and the outcome of contingencies.
Any or all of our forward-looking statements in this report may turn out to be wrong.
They can be affected by inaccurate assumptions we might make or by known or unknown risks and
uncertainties. Consequently, no forward-looking statement can be guaranteed. Actual results may
vary materially from those set forth in forward-looking statements. The uncertainties that may
cause differences include, but are not limited to: the Companys history of losses, anticipated
continuing losses and uncertainty of future revenues or profitability; the early stage of product
development; uncertainties as to the future success of ongoing and planned clinical trials; the
unproven safety and efficacy of products under development; the sufficiency of the Companys
existing capital resources; the possible need for additional funds; uncertainty of future funding;
the Companys dependence on others for much of the clinical development of its product candidates
under development, as well as for obtaining regulatory approvals and conducting manufacturing and
marketing of any product candidates that might successfully reach the end of the development
process; the impact of government regulations, health care reform and managed care; competition
from other companies and other institutions pursuing the same, alternative or superior
technologies; the risk of technological obsolescence; uncertainties related to the Companys
ability to obtain adequate patent and other intellectual property protection for its proprietary
technology and product candidates; dependence on officers, directors and other individuals; and
risks related to product liability exposure.
We will not update forward-looking statements, whether as a result of new information,
future events or otherwise, unless required by law. You are advised to consult any further
disclosures we make in our reports to the Securities and Exchange Commission, including our reports
on Form 10-Q, 8-K and 10-K. Our filings list various important factors that could cause actual
results to differ materially from expected results. We note these factors for investors as
permitted by the Private Securities Litigation Reform Act of 1995. You should understand that it is
not possible to predict or identify all such factors. Consequently, you should not consider any
such list to be a complete set of all potential risks or uncertainties.
2
INDEX
3
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PART IFINANCIAL INFORMATION
Item 1. Financial StatementsUnaudited
OXiGENE, Inc.
Condensed Balance Sheets
(All amounts in thousands, except per share data)
(Unaudited)
(All amounts in thousands, except per share data)
(Unaudited)
September 30, 2008 | December 31, 2007 | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 8,755 | $ | 8,527 | ||||
Available-for-sale securities |
2,330 | 19,911 | ||||||
Prepaid expenses |
1,023 | 354 | ||||||
Other current assets |
16 | 72 | ||||||
Total current assets |
12,124 | 28,864 | ||||||
Furniture and fixtures, equipment and leasehold improvements |
1,416 | 1,343 | ||||||
Accumulated depreciation |
(1,223 | ) | (1,122 | ) | ||||
193 | 221 | |||||||
License agreement, net of accumulated amortization of $895 and $822 at
September 30, 2008 and December 31, 2007, respectively |
606 | 679 | ||||||
Other assets |
188 | 300 | ||||||
Total assets |
$ | 13,111 | $ | 30,064 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable. |
967 | 1,370 | ||||||
Accrued research and development |
4,256 | 2,713 | ||||||
Accrued other |
800 | 901 | ||||||
Total current liabilities |
6,023 | 4,984 | ||||||
Rent loss accrual |
72 | 223 | ||||||
Total liabilities |
6,095 | 5,207 | ||||||
Commitments and contingencies |
||||||||
Stockholders equity: |
||||||||
Common stock, $.01 par value, 100,000 shares authorized; 29,176
shares at September 30, 2008 and 28,505 shares at December 31, 2007,
issued and outstanding |
292 | 285 | ||||||
Additional paid-in capital |
164,337 | 162,358 | ||||||
Accumulated deficit |
(157,401 | ) | (137,801 | ) | ||||
Accumulated other comprehensive income |
(212 | ) | 15 | |||||
Total stockholders equity |
7,016 | 24,857 | ||||||
Total liabilities and stockholders equity |
$ | 13,111 | $ | 30,064 | ||||
See accompanying notes.
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OXiGENE, Inc.
Condensed Statements of Operations
(All amounts in thousands, except per share data)
(Unaudited)
(All amounts in thousands, except per share data)
(Unaudited)
Three months ended | Nine months ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2008 | 2007 | 2008 | 2007 | |||||||||||||
License Revenue: |
$ | 13 | $ | | $ | 13 | $ | 7 | ||||||||
Operating costs and expenses: |
||||||||||||||||
Research and development |
5,004 | 3,745 | 13,869 | 9,636 | ||||||||||||
General and administrative |
2,234 | 1,984 | 6,304 | 6,488 | ||||||||||||
Total operating costs and expenses |
7,238 | 5,729 | 20,173 | 16,124 | ||||||||||||
Loss from operations |
(7,225 | ) | (5,729 | ) | (20,160 | ) | (16,117 | ) | ||||||||
Investment income |
102 | 467 | 546 | 1,562 | ||||||||||||
Other income (expense), net |
15 | (13 | ) | 13 | (37 | ) | ||||||||||
Net loss |
$ | (7,108 | ) | $ | (5,275 | ) | $ | (19,601 | ) | $ | (14,592 | ) | ||||
Basic and diluted net loss per common share |
$ | (0.25 | ) | $ | (0.19 | ) | $ | (0.69 | ) | $ | (0.52 | ) | ||||
Weighted-average number of common shares outstanding |
28,816 | 27,938 | 28,374 | 27,896 |
See accompanying notes.
5
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OXiGENE, Inc.
Condensed Statements of Cash Flows
(All amounts in thousands)
(Unaudited)
(All amounts in thousands)
(Unaudited)
Nine months ended September 30, | ||||||||
2008 | 2007 | |||||||
Operating activities: |
||||||||
Net loss |
$ | (19,601 | ) | $ | (14,592 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Depreciation |
101 | 85 | ||||||
Other-than-temporary impairment of available-for-sale securities |
6 | | ||||||
Amortization of license agreement |
73 | 74 | ||||||
Rent loss accrual |
(217 | ) | (65 | ) | ||||
Stock-based compensation |
1,158 | 1,687 | ||||||
Changes in operating assets and liabilities: |
||||||||
Prepaid expenses and other current assets |
(610 | ) | (176 | ) | ||||
Accounts payable, accrued expenses and other payables |
1,105 | 797 | ||||||
Net cash used in operating activities |
(17,986 | ) | (12,190 | ) | ||||
Investing activities: |
||||||||
Purchase of available-for-sale securities |
(4,314 | ) | (28,321 | ) | ||||
Proceeds from sale of available-for-sale securities |
21,662 | 37,148 | ||||||
Purchase of furniture, fixtures and equipment |
(73 | ) | (85 | ) | ||||
Other assets |
112 | (411 | ) | |||||
Net cash provided by investing activities |
17,387 | 8,331 | ||||||
Financing activities: |
||||||||
Proceeds from issuance of common stock, net of acquisition costs |
827 | | ||||||
Net cash provided by financing activities |
827 | | ||||||
Increase (Decrease) in cash and cash equivalents |
228 | (3,859 | ) | |||||
Cash and cash equivalents at beginning of period |
8,527 | 15,687 | ||||||
Cash and cash equivalents at end of period |
$ | 8,755 | $ | 11,828 | ||||
See accompanying notes.
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OXiGENE, Inc.
Notes to Condensed Financial Statements
September 30, 2008
(Unaudited)
September 30, 2008
(Unaudited)
1. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed financial statements have been prepared in
accordance with U.S. generally accepted accounting principles for interim financial information and
with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not
include all of the information and footnotes required by U.S. generally accepted accounting
principles for complete financial statements. In the opinion of management, all adjustments
(consisting primarily of normal recurring accruals) considered necessary for a fair presentation
have been included. Operating results for the nine months ended September 30, 2008 are not
necessarily indicative of the results that may be expected for the year ending December 31, 2008.
The balance sheet at December 31, 2007 has been derived from the audited financial statements
at that date but does not include all of the information and footnotes required by generally
accepted accounting principles for complete financial statements. For further information, refer to
the financial statements and footnotes thereto included in the Annual Report on Form 10-K for
OXiGENE, Inc. (the Company) for the year ended December 31, 2007, which can be found at
www.oxigene.com.
The Company has experienced net losses and negative cash flow from operations each year since
its inception, except in fiscal 2000. As of September 30, 2008, OXiGENE had an accumulated deficit
of approximately $157,401,000. The Company expects to continue to incur expenses, resulting in
operating losses, over the next several years due to, among other factors, our continuing clinical
trials, planned future clinical trials, and other anticipated research and development activities.
OXiGENEs cash, cash equivalents and available-for-sale securities balance was approximately
$11,085,000 at September 30, 2008. Based on current plans, the Company expects its current
available cash and cash equivalents to meet its cash requirements into the first quarter of fiscal
2009. The Company will require significant additional funding to remain a going concern and to
fund operations until such time, if ever, it becomes profitable. The Company intends to augment its
cash, cash equivalents and marketable securities balances as of September 30, 2008 with the
utilization of its Committed Equity Financing Facility (See Note 3 Agreements), if available by
its terms, as well as through other forms of capital infusion, including strategic alliances with
organizations that have capabilities and/or products that are complementary to the Companys
capabilities and products in order to continue the development of its potential product candidates.
However, there can be no assurance that adequate additional financing under such arrangements will
be available to the Company on terms that it deems acceptable, if at all. Therefore, there exists
substantial doubt about the Companys ability to continue as a going concern. No adjustments have
been made to carrying value of the assets and /or liabilities in these condensed financial
statements based on this uncertainty.
Available-for-Sale Securities
In accordance with the Companys investment policy, surplus cash is invested primarily in
investment-grade corporate bonds, commercial paper, U.S. government agency debt securities, and
certificates of deposit. In accordance with Statement of Financial Accounting Standards No. 115
(SFAS 115), Accounting for Certain Investments in Debt and Equity Securities, the Company
separately discloses cash and cash equivalents from investments in marketable securities. The
Company designates its marketable securities as available-for-sale securities. Available-for-sale
securities are carried at fair value with the unrealized gains and losses, net of tax, if any,
reported as accumulated other comprehensive income (loss) in stockholders equity. The Company
reviews the status of the unrealized gains and losses of its available-for-sale marketable
securities on a regular basis. Realized gains and losses and declines in value judged to be
other-than-temporary on available-for-sale securities are included in investment income. Interest
and dividends on securities classified as available-for-sale are included in investment income.
The Companys investment objectives are to preserve principal, maintain a high degree of
liquidity to meet operating needs and obtain competitive returns subject to prevailing market
conditions. The Company assesses the market risk of its investments on an ongoing basis so as to
avert risk of loss. The Company assesses the market risk of its investments by continuously
monitoring the market prices of its investments and related rates of return, continuously looking
for the safest, most risk-averse investments that will yield the highest rates of return in their
category.
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The following is a summary of the fair values of the Companys available-for-sale securities:
(amounts in thousands)
September 30, 2008 | December 31, 2007 | |||||||
Corporate bonds maturing in less than one year |
$ | 1,031 | $ | 5,819 | ||||
Commercial paper maturing in less than one year |
299 | 10,703 | ||||||
Asset backed securities maturing in less than
one year |
1,000 | 3,389 | ||||||
Total available-for-sale securities |
$ | 2,330 | $ | 19,911 | ||||
As of September 30, 2008, the Companys available-for-sale securities are at a net unrealized loss
position totaling approximately $212,000. During the month of September the Company recorded an
unrealized loss of $204,000 related to a $750,000 corporate bond issued by American General Finance
that matures on May 15, 2009.
SFAS 115 requires that a company recognize in earnings all declines in fair value below the
cost basis that are considered other -than-temporary. The Company considered, among other factors
that the decline in fair value was abrupt and has not existed for an extended period of time, the
financial condition of the issuer (AIG) has the support of a significant U.S. Government bailout,
the decline in fair value was not specific to this corporate bond but to the overall market
conditions as a whole and in reviewing the debt securities that have matured in the last quarter
the Company noted investors of these debt securities received full principal payment on the
respective maturity dates. The Company has the intent and ability to hold this corporate bond
until maturity and expects to receive the full recovery of the bonds value and concluded that the
decline in value is not other than temporary.
Fair Value
In September 2006, the Financial Accounting Standards Board (FASB) issued Statement of
Financial Accounting Standards (SFAS) No. 157, Fair Value Measurements. SFAS 157 effective for
financial statements issued for fiscal years beginning after November 15, 2007. SFAS 157 replaces
multiple existing definitions of fair value with a single definition, establishes a consistent
framework for measuring fair value and expands financial statement disclosures regarding fair value
measurements. This Statement applies only to fair value measurements that already are required or
permitted by other accounting standards and does not require any new fair value measurements. In
February 2008, the FASB issued FASB Staff Position (FSP) No. 157-2, which delayed the effective
date of SFAS No. 157 until the first quarter of 2009 for nonfinancial assets and liabilities that
are not recognized or disclosed at fair value in the financial statements on a recurring basis.
The adoption of SFAS 157 for our financial assets and liabilities in the first quarter of
2008 did not have a material impact on our financial position or results of operations. Pursuant to
the provisions of SFAS 157, we are required to disclose information on all assets and liabilities
reported at fair value that enables an assessment of the inputs used in determining the reported
fair values. SFAS 157 establishes a fair value hierarchy that prioritizes valuation inputs based on
the observable nature of those inputs. The SFAS 157 fair value hierarchy applies only to the
valuation inputs used in determining the reported fair value of our investments and is not a
measure of the investment credit quality. The hierarchy defines three levels of valuation inputs:
Level 1 inputs
|
Quoted prices in active markets; | |
Level 2 inputs
|
Generally include inputs with other observable qualities, such as quoted prices in active markets for similar assets or quoted prices for identical assets in inactive markets; and | |
Level 3 inputs
|
Valuations based on unobservable inputs. |
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The following table summarizes our assets that were measured at fair value as of September 30, 2008
(in thousands):
Fair Value Measurement at Reporting Date Using: | ||||||||||||||||
Significant Other | Significant | |||||||||||||||
Quoted Prices in | Observable | Unobservable | ||||||||||||||
Active Markets | Inputs | Inputs | Fair Value | |||||||||||||
(Level 1) | (Level 2) | (Level 3) | September 30, 2008 | |||||||||||||
Cash Equivalents |
||||||||||||||||
Money Market Fund |
$ | 6,185 | $ | | $ | | $ | 6,185 | ||||||||
Total Cash Equivalents |
6,185 | | | 6,185 | ||||||||||||
Available for Sale |
||||||||||||||||
Corporate Bonds |
| $ | 1,031 | | 1,031 | |||||||||||
Commercial paper |
| 299 | | 299 | ||||||||||||
Asset-backed securities |
| 1,000 | | 1,000 | ||||||||||||
Total Available for
Sale |
| 2,330 | | 2,330 | ||||||||||||
Total |
$ | 6,185 | $ | 2,330 | $ | | $ | 8,515 | ||||||||
Cash of $2,570,000 is not included in our SFAS 157 level hierarchy disclosure.
Accrued Research and Development
The Company charges all research and development expenses, both internal and external
costs, to operations as incurred. The Companys research and development costs represent expenses
incurred from the engagement of outside professional service organizations, product manufacturers
and consultants associated with the development of the Companys potential product candidates. The
Company recognizes expense associated with these arrangements based on the completion of activities
as specified in the applicable contracts. Costs incurred under fixed fee contracts are accrued
ratably over the contract period absent any knowledge that the services will be performed other
than ratably. Costs incurred under contracts with clinical trial sites and principal investigators
are generally accrued on a patient-treated basis consistent with the terms outlined in the
contract. In determining costs incurred on some of these programs, the Company takes into
consideration a number of factors, including estimates and input provided by internal program
managers. Upon termination of such contracts, the Company is normally only liable for costs
incurred and committed to date. As a result, accrued research and development expenses represent
the Companys estimated contractual liability to outside service providers at any relevant time.
Net Loss Per Share
Basic and diluted net loss per share was calculated in accordance with the provisions of
Statement of Financial Accounting Standards No. 128, Earnings Per Share, by dividing the net loss
per share by the weighted-average number of common shares outstanding. Diluted net loss per share
includes the effect of all dilutive, potentially issuable common equivalent shares as defined using
the treasury stock method. All of the Companys common stock equivalents are anti-dilutive due to
the Companys net loss position for all periods presented. Accordingly, common stock equivalents of
approximately 2,813,000 and 2,798,000 at September 30, 2008 and 2007, respectively, were excluded
from the calculation of weighted average shares for diluted net loss per share.
Stock-based Compensation
The Company follows the provisions of Statement of Financial Accounting Standards
No. 123R, Share-Based Payment (SFAS 123R), which requires the expense recognition of the
estimated fair value of all share-based payments issued to employees.
For the three and nine months ended September 30, 2008, the Company recorded approximately $450,000
and $1,160,000 of expense associated with share-based compensation, respectively. For the three
and nine months ended September 30, 2007, the Company recorded approximately $586,000 and
$1,687,000 of expense associated with share-based compensation, respectively.
The Companys stock options are valued using the Black-Scholes option pricing model, and
the resulting fair value is recorded as compensation cost on a straight-line basis over the
performance period, which is generally the same as the option vesting period.
During the three and nine months ended September 30, 2008, options to purchase 20,000 and
64,000 shares, respectively, of the Companys common stock were granted, with 20,000 of those
options being granted to non-employees. The weighted average fair values of the options granted
based on the assumptions outlined in the table below were $0.62 and $0.93 per share, respectively,
for
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the three and nine months ended September 30, 2008. During the three and nine months ended
September 30, 2007, options to purchase 200,000 and 637,000 shares, respectively, of the Companys
common stock were granted. The weighted average fair values of the options granted based on the
assumptions outlined in the table below were $2.59 and $2.50 per share, respectively, for the
three and nine months ended September 30, 2007.
In April 2007, the Company granted options to purchase 100,000 shares of its common stock
to its Chief Operating Officer, who is now the Companys Chief Executive Officer, at a grant price
of $4.69 per share. The options were valued using the Black-Scholes option pricing model with
assumptions consistent with other options granted by the Company. These options shall vest upon the
achievement of milestones as outlined in this executives employment agreement and approved by the
Board of Directors. As of September 30, 2008, the Company determined that the achievement of the
milestones as outlined in this executives employment
agreement is not probable and accordingly, no compensation expense has been recorded for these
options for the period to date.
The fair values for the stock options granted in the 2008 year to date period were
estimated at the date of grant using the Black-Scholes option pricing model with the following
weighted-average assumptions for the three and nine months ended September 30, 2008 and three and
nine months ended September 30, 2007:
Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
2008 | 2007 | 2008 | 2007 | |||||||||||||
Weighted Averge Assumptions |
||||||||||||||||
Risk-free interest rate |
3.13 | % | 4.62 | % | 3.06 | % | 4.62 | % | ||||||||
Expected life |
5 years | 5 years | 5 years | 5 years | ||||||||||||
Expected volatility |
54 | % | 86 | % | 62 | % | 88 | % | ||||||||
Dividend yield |
0.00 | % | 0.00 | % | 0.00 | % | 0.00 | % |
Options, Warrants and Non-Vested Stock
The following is a summary of the Companys stock option activity under its 1996 and 2005
Stock Plans for the nine months ended September 30, 2008:
Weighted Average | ||||||||||||||||
Weighted Average | Remaining | Aggregate | ||||||||||||||
Shares | Exercise Price | Contractual Life | Intrinsic Value | |||||||||||||
(In thousands) | (Years) | (In thousands) | ||||||||||||||
Options outstanding at December 31, 2007 |
2,148 | $ | 5.61 | 7.07 | $ | 44 | ||||||||||
Granted |
64 | $ | 1.51 | | | |||||||||||
Exercised |
| | | |||||||||||||
Forfeited |
(23 | ) | $ | 3.76 | | | ||||||||||
Options outstanding at September 30, 2008 |
2,189 | $ | 5.53 | 6.43 | $ | | ||||||||||
Option exercisable at September 30, 2008 . |
1,531 | $ | 6.30 | 5.54 | | |||||||||||
Options vested or expected to vest at September 30, 2008 |
2,164 | $ | 5.53 | 6.43 | $ | | ||||||||||
As of September 30, 2008, there was approximately $842,000 of unrecognized compensation cost
related to stock option awards that is expected to be recognized as expense over a weighted average
period of 1.5 years. The total fair value of stock options that vested during the nine months ended
September 30, 2008 and 2007 was approximately $1,063,000 and $482,000, respectively.
In the nine months ended September 30, 2008, the Company awarded 20,000 options to purchase
common stock of the Company to two non-employees at an exercise price of $1.29 which vest in equal
installments over four years. The Company will record expense for these options in accordance with
FAS 123R and EITF 96-18.
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Non-Vested Stock
The following table summarizes the activity for unvested stock in connection with restricted
stock grants during the nine months ended September 30, 2008:
Weighted Average | ||||||||
Shares | Fair Value | |||||||
(In thousands) | ||||||||
Unvested at December 31, 2007 |
468 | $ | 4.73 | |||||
Granted |
| |||||||
Vested |
(93 | ) | $ | 4.67 | ||||
Forfeited |
| | ||||||
Unvested at September 30, 2008 |
375 | $ | 4.75 | |||||
The Company recorded expense of approximately $230,000 and $622,000 related to outstanding
restricted stock awards during the three and nine months ended September 30, 2008, respectively. As
of September 30, 2008, there was approximately $1,103,000 of unrecognized compensation expense
related to restricted stock awards that will be recognized as expense over a weighted average
period of 1.3 years.
In January 2007, the Company granted 250,000 shares of restricted common stock to its former
Chief Executive Officer pursuant to his employment agreement. In September 2007, the Company
granted an aggregate of 80,000 shares of restricted common stock to two new members of the Board of
Directors. The restricted stock awards were valued based on the closing price of the Companys
common stock on their respective grant dates. Compensation expense is being recognized on a
straight line basis over the vesting period of the awards.
Warrants
In September 2003, the Company issued five-year warrants in connection with a private
placement with three large institutional investors. As of September 30, 2008, all of these warrants
have expired without being exercised.
In February 2008, the Company issued five year warrants to purchase common stock
exercisable beginning six months after February 19, 2008 to Kingsbridge Capital Limited in
consideration for entering into a Committed Equity Financing Facility. Kingsbridge may purchase
from the Company up to 250,000 shares of common stock at an exercise price of $2.74 per share. As
of September 30, 2008, none of these warrants were exercisable.
Comprehensive Income (Loss)
The Companys only item of other comprehensive income (loss) relates to unrealized gains
and losses on available-for-sale securities and is presented separately on the balance sheet, as
required.
A reconciliation of comprehensive loss is as follows:
Three months ended | Nine months ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2008 | 2007 | 2008 | 2007 | |||||||||||||
(In thousands) | ||||||||||||||||
Net loss as reported |
$ | (7,108 | ) | $ | (5,275 | ) | $ | (19,601 | ) | $ | (14,592 | ) | ||||
Unrealized gains |
(220 | ) | 18 | (227 | ) | 23 | ||||||||||
Comprehensive loss |
$ | (7,328 | ) | $ | (5,257 | ) | $ | (19,828 | ) | $ | (14,569 | ) | ||||
2. License Agreements
In August 1999, the Company entered into an exclusive license for the commercial development,
use and sale of products or services covered by certain patent rights owned by Arizona State
University. The Company has paid a total of $1,800,000 in connection with the initial terms of the
license. The Company capitalized the net present value of the total amount paid, or $1,500,000, and
is amortizing this amount over the patent life or 15.5 years. In September 2002, this agreement was
amended and provides for additional payments in connection with the license arrangement upon the
initiation of certain clinical trials or the completion of certain
regulatory approvals, which payments could be accelerated upon the achievement of certain
financial milestones, as defined in the
11
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agreement. The license agreement also provides for
additional payments upon the Companys election to develop certain additional compounds, as defined
in the agreement. As of September 30, 2008, additional accelerated payments that have previously
been expensed and paid, due to achievement of certain financial milestones, totaled $700,000, and
future milestone payments under this agreement could total up to an additional $200,000. These
accelerated payments were expensed to research and development as triggered by the achievements
defined in the agreement. The Company is also required to pay royalties on future net sales of
products associated with these patent rights.
In March 2007, the Company entered into an exclusive license agreement for the
development and commercialization of products covered by certain patent rights owned by Intracel
Holdings, Inc., a privately held corporation. The Company paid Intracel $150,000 in March 2007 as
an up-front license fee that provides the Company with full control over the development and
commercialization of licensed compounds/molecular products. The Company expensed the up-front
payment to research and development expense. The agreement provides for additional payments by the
Company to Intracel based on the achievement of certain clinical milestones and royalties based on
the achievement of certain sales milestones. The Company has the right to sublicense all or
portions of its licensed patent rights under this agreement.
3. Agreements
In February 2008, the Company entered into a Committed Equity Financing Facility, or CEFF
with Kingsbridge Capital Limited, or Kingsbridge, pursuant to which Kingsbridge committed to
purchase, subject to certain conditions, up to 5,708,035 shares of the Companys common stock or up
to an aggregate of $40,000,000 during the three years from the date of the agreement. Under the
CEFF, the Company is able to draw down shares in tranches of up to a maximum of 3.5 % of its
closing market value at the time of the draw down or the alternative draw down amount calculated
pursuant to the Common Stock Purchase Agreement whichever is less, subject to certain conditions.
The purchase price of these shares will be at a discount of between 5 and 12 % from the volume
weighted average price of the Companys common stock for each of the eight trading days following
the election to sell shares. Kingsbridge is not obligated to purchase shares if the volume weighted
average price of our stock is less than $1.25 per share or 85% of the closing share price of the
Companys stock on the trading day immediately preceding the commencement of the draw down,
whichever is higher. In connection with the CEFF, the Company issued a warrant to Kingsbridge to
purchase 250,000 shares of its common stock at a price of $2.74 per share exercisable beginning six
months after February 19, 2008 for a period of five years thereafter. The fair value of the warrant
was determined on the date of issuance using the Black-Scholes option valuation model applying the
following assumptions: (i) a risk-free interest rate of 2.75% ( ii) an expected term of 5.5 years,
which represents the contractual term (iii) no dividend yield and (iv) volatility of 83%. The
estimated fair value of this warrant was $349,000, which was recorded as contra-equity within
additional paid in capital.
In connection with the CEFF, the Company entered into a Registration Rights Agreement, or
RRA with Kingsbridge. The RRA is effective through the term of the CEFF and for two years
thereafter. Pursuant to the RRA, the Company was required to file a registration statement with
respect to the resale of the shares of common stock issuable under the CEFF and the warrant within
60 days after entering into the CEFF and to use commercially reasonable efforts to have such
registration statement declared effective by the SEC within 180 days of entering into the CEFF. The
RRA requires the Company to maintain effectiveness of the registration statement throughout the
term of the RRA. If the Company (1) fails to maintain effectiveness of the registration statement,
or (2) has a deferral or suspension of registration due to a black-out period, the Company may be
subject to liquidated damages. The liquidated damages are equal to the loss that Kingsbridge would
incur by holding shares of the Companys common stock and being unable to sell those shares because
of an ineffective registration statement or black-out period. There is no limit to the amount of
the liquidated damages that could be received in those circumstances. In accordance with the RRA,
the Company has filed a Registration Statement on Form S-1 (File No. 333-150595) with the SEC,
which was declared effective on May 15, 2008. As of September 30, 2008, the Company has not
accrued for any liquidated damages. The Company received net proceeds of $900,000 from the sale of
approximately 635,000 shares of common stock under the CEFF during the nine months ended September
30, 2008.
4. Subsequent Events
On October 1, 2008, OXiGENE entered into a series of related agreements with Symphony Capital
LLC or Symphony, Symphony ViDA, Inc. or ViDA, Symphony ViDA Holdings LLC or Holdings and
related entities, including the following:
| Purchase Option Agreement; | ||
| Research and Development Agreement; | ||
| Amended and Restated Research and Development Agreement; | ||
| Technology License Agreement; | ||
| Novated and Restated Technology License Agreement; | ||
| Confidentiality Agreement; and | ||
| Additional Funding Agreement. |
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In addition, on October 1, 2008, OXiGENE entered into a series of related agreements with Holdings,
including the following:
| Stock and Warrant Purchase Agreement; | ||
| Warrant to purchase up to 11,281,877 shares of OXiGENE common stock; and | ||
| Registration Rights Agreement. |
Pursuant to these agreements, Holdings has formed and capitalized ViDA, a newly formed
Delaware corporation, in order (a) to hold certain intellectual property related to two of
OXiGENEs product candidates, ZYBRESTAT for use in ophthalmologic indications and OXi4503 referred
to as the Programs, which were exclusively licensed to ViDA under the Novated and Restated
Technology License Agreement and (b) to fund commitments in the amount of up to $25,000,000. The
funding will support pre-clinical and clinical development by OXiGENE, on behalf of ViDA, of the
Programs. Under certain circumstances, the Company may be required to commit up to $15,000,000 to
ViDA. The Company is developing a topical formulation of ZYBRESTAT for ophthalmologic diseases
and conditions, such as age-related macular degeneration, that are characterized by abnormal blood
vessel growth within the eye that results in loss of vision. The Company currently plans to
undertake a series of preclinical and clinical studies with the objective of demonstrating the
utility of a topical formulation of ZYBRESTAT in an ophthalmologic indication. OXi4503 is currently
in a Phase I clinical trial in patients with advanced solid tumors. Based on favorable results in
preclinical studies, the Company currently plans to undertake further clinical trials with OXi4503
in AML and hepatic tumors.
The Purchase Option Agreement provides for the exclusive right, but not the obligation, of
OXiGENE to repurchase both Programs by acquiring 100% of the equity of ViDA at any time between
October 2, 2009 and March 31, 2012 for an amount equal to two times the amount of capital actually
invested by Holdings in ViDA,, less certain amounts. The purchase price is payable in cash or a
combination of cash and shares of OXiGENE common stock (up to 20% of the purchase price or 10% of
the total number of shares of OXiGENE common stock outstanding at such time, whichever is less), in
OXiGENEs sole discretion, subject to certain limitations. If OXiGENE does not exercise its
exclusive right with respect to the purchase of the Programs licensed under the agreement with
ViDA, rights to the Programs at the end of the development period will remain with ViDA.
OXiGENE has issued to Holdings, pursuant to the Stock and Warrant Purchase Agreement, (1) an
aggregate of 5,835,241 shares of OXiGENE common stock (the Shares), and (2) a ten-year warrant to
purchase 11,281,877 shares of OXiGENE common stock (the Warrant) at an exercise price of $1.11
per share, the closing price of OXiGENE common stock on The NASDAQ Global Market on September 30,
2008, the day before the consummation of the Symphony transaction. OXiGENE may issue additional
shares of its common stock and warrants in the event of specified events under the Additional
Funding Agreement, the Novated and Restated Technology License Agreement and the Purchase Option
Agreement. OXiGENE has agreed to provide certain registration rights under the Securities Act of
1933, as amended (the Securities Act) with respect to the shares issued and to be issued to
Holdings under these agreements.
The Amended and Restated Research and Development Agreement provides that the conduct of the
activities under the mutually agreed upon development plan and budget during the development period
will be undertaken primarily by OXiGENE with support from RRD International LLC, the clinical
development partner of Symphony, and provides that the development will be overseen by a
Development Committee which is comprised of six representatives, three representatives to be
designated by OXiGENE and three representatives to be designated by Holdings. The Development
Committee will report to the board of directors of ViDA, which will be comprised of John Kollins,
OXiGENEs Chief Executive Officer, two representatives of Symphony, Mark Kessel and Jeffrey S.
Edelman, and two independent board members.
In addition, OXiGENE has given Holdings the right to appoint two members to its Board of Directors.
Holdings has designated Mark Kessel and Alastair J.J. Wood M.D., both Managing Directors of
Symphony Capital LLC, as the Holdings representatives, who were appointed to the Board on October
22, 2008.
5. Recent Accounting Pronouncements
In December 2007, the Financial Accounting Standards Board FASB issued Statement of
Financial Accounting Standards SFAS No. 141 (revised 2007) (SFAS 141R), entitled Business
Combinations. SFAS 141R will change how business acquisitions are accounted for and will impact
financial statements both on the acquisition date and in subsequent periods. SFAS 141R will be
effective prospectively for business combinations for which the acquisition date is on or after the
beginning of the first annual reporting period beginning on or after December 15, 2008. The Company
does not expect the adoption of SFAS 141R to have a material effect on its financial position or
results of operations.
In December 2007, the Emerging Issues Task Force (EITF) issued EITF 07-1 entitled
Accounting for Collaborative Arrangements. EITF 07-1 defines collaborative arrangements and
establishes reporting requirements for transactions between participants in a collaborative
arrangement and between participants in the arrangement and third parties. EITF 07-1 will be
effective for fiscal years beginning after December 15, 2008. The Company does not expect the
adoption of EITF 07-1 to have a material effect
on its financial position or results of operations.
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In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated Financial
Statements, an amendment of ARB No. 51 (SFAS 160). SFAS 160 changes the accounting for
noncontrolling (minority) interests in consolidated financial statements including the requirements
to classify noncontrolling interests as a component of consolidated stockholders equity, and the
elimination of minority interest accounting in results of operations with earnings attributable
to noncontrolling interests reported as part of consolidated earnings. Additionally, SFAS 160
revises the accounting for both increases and decreases in a parents controlling ownership
interest. SFAS 160 is effective for the Company in fiscal 2009, with early adoption prohibited. The
Company is currently evaluating what impact, if any, the adoption of SFAS 160 will have on its
financial position or results of operations.
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Our Managements Discussion and Analysis of Financial Condition and Results of Operations
as of September 30, 2008 and September 30, 2007 should be read in conjunction with the sections of
our audited consolidated financial statements and notes thereto, as well as our Managements
Discussion and Analysis of Financial Condition and Results of Operations that is included in our
Annual Report on Form 10-K for the year ended December 31, 2007, and also with the unaudited
financial statements set forth in Part I, Item 1 of this Quarterly Report.
Overview
We are a clinical-stage, biopharmaceutical company developing novel therapeutics to treat
cancer and eye diseases. Our primary focus is the development and commercialization of product
candidates referred to as vascular disrupting agents (VDAs) that selectively disrupt abnormal blood
vessels associated with solid tumor progression and visual impairment in a number of ocular
diseases which are characterized by abnormal blood vessel growth. Because our VDA product
candidates act via a validated therapeutic mechanism, inhibition of blood flow to tumors and
neovascular lesions within the eye, we believe the risk associated with its drug development
programs is relatively low.
Our most advanced therapeutic product candidate, ZYBRESTAT (generic name fosbretabulin,
previously known as combretastatin A4 phosphate or CA4P), is currently being evaluated in a Phase
II/III pivotal registration study as a potential treatment for anaplastic thyroid cancer, a highly
aggressive and lethal malignancy for which there are currently no approved therapeutics and
extremely limited treatment options. In addition, ZYBRESTAT is being evaluated in Phase II
clinical trials as a potential treatment for: (i) non-small cell lung cancer (NSCLC) in
combination with the chemotherapeutic agents, carboplatin and paclitaxel, and the anti-angiogenic
agent, bevacizumab; and (ii) platinum resistant ovarian cancer in combination with carboplatin and
paclitaxel. We believe that these studies, if successful, will establish a compelling rationale
for further development of ZYBRESTAT as a treatment (i) for other forms of recurrent, metastatic
thyroid cancer; (ii) for other aggressive and difficult-to-treat malignancies; (iii) for use in
combination with chemotherapy in a variety of solid tumors in which carboplatin and paclitaxel
chemotherapy are commonly used; and (iv) for use in combination with anti-angiogenic agents in
other solid tumors in which anti-angiogenic therapies are commonly used. We believe these areas
for potential further development collectively represent a very large potential commercial market
opportunity. In addition, based upon preclinical results first published by our collaborators in
the November 2007 online issue of the journal Blood, we believe that ZYBRESTAT and its other VDA
product candidates may also have utility in the treatment of hematological malignancies or liquid
tumors. Approximately 350 subjects have been treated to date with ZYBRESTAT in human clinical
trials.
In addition to developing ZYBRESTAT as an intravenously administered therapy for cancer
indications, We are developing a topical formulation of ZYBRESTAT for ophthalmological diseases and
conditions, such as age-related macular degeneration (AMD) that are characterized by abnormal
blood vessel growth within the eye that results in loss of vision. We believe that a safe,
effective, convenient topically-administered anti-vascular therapeutic would have advantages over
currently-approved anti-vascular, ophthalmological therapeutics, which must be injected directly
into patients eyes on a frequent basis. In addition to having potential utility for treating
ocular diseases and conditions such as AMD that affect tissues such as the choroid in the back of
the eye, we believe that a topical ophthalmological formulation of ZYBRESTAT could also have
utility for the treatment of other ocular diseases and conditions that affect tissues in the front
of the eye, such as the cornea and iris, which are characterized by abnormal growth of blood
vessels, or neovascularization. We currently plan to undertake a series of preclinical and
clinical studies with the objective of demonstrating the utility of a topical formulation of
ZYBRESTAT in an ophthalmologic indication.
We are currently evaluating a second-generation VDA product candidate, OXi4503, in a Phase I
clinical trial in patients with advanced solid tumors. We refer to OXi4503 as an ortho-quinone
prodrug (OQP). In preclinical studies, OXi4503 has shown potent anti-tumor activity, both as a
single-agent and in combination with other cancer treatment modalities. We believe that OXi4503 is
differentiated from other VDAs by its ability to exert (i) potent vascular disrupting effects on
tumor vasculature; and (ii) direct cytotoxic effects on tumor cells. OXi4503 is currently in a
Phase I clinical trial in patients with advanced solid tumors. Based on favorable results in
preclinical studies, we currently plan to undertake further clinical trials with OXi4503 in acute
myeloid leukemia (AML) and hepatic tumors.
Both ZYBRESTAT for use in ophthalmologic indications and OXi4503, referred to as the
Programs, were exclusively licensed to Symphony ViDA Holdings LLC under a Novated and Restated
Technology License Agreement on October 1, 2008 (See Note 4, Subsequent Events to Condensed
Financial Statements above)
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Finally, under a sponsored research agreement with Baylor University, we are pursuing
discovery and development of novel, small-molecule therapeutics for the treatment of cancer that we
believe will be complementary with our later-stage VDA product candidates.
We are committed to a disciplined financial strategy and as such maintain a limited employee
and facilities base, with development, scientific, finance and administrative functions, which
include, among other things, product development, regulatory oversight and clinical testing. Our
research and development team members typically work on a number of development projects
concurrently. Accordingly, we do not separately track the costs for each of these research and
development projects to enable separate disclosure of these costs on a project-by-project basis. We
conduct substantial scientific activities pursuant to collaborative arrangements with universities.
Regulatory and clinical testing functions are generally contracted out to third-party, specialty
organizations.
We will require significant additional funding to remain a going concern and to fund
operations until such time, if ever, we become profitable. However, there can be no assurance that
adequate additional financing will be available to us on terms that we deem acceptable, if at all.
Our failure to successfully complete human clinical trials, develop and market products over the
next several years, or to realize product revenues, would materially adversely affect our business,
financial condition and results of operations. Royalties or other revenue generated by us from
commercial sales of our potential products are not expected for several years, if at all.
We have generated a cumulative net loss of approximately $157,401,000 for the period from our
inception through September 30, 2008. We expect to incur significant additional operating losses
over at least the next several years, principally as a result of our continuing clinical trials and
anticipated research and development expenditures. The principal source of our working capital has
been the proceeds of private and public equity financings and the exercise of warrants and stock
options. We currently have no material amount of licensing or other fee income. As of September 30,
2008, we had no long-term debt or loans payable.
Results of Operations
Nine Months Ended September 30, 2008 and 2007
Revenue
We reported $13,000 and $7,000 in license revenue for the nine months ended September 30, 2008
and 2007, respectively. Currently, our only source of revenue is from the license to a third party
of our formerly owned nutritional and diagnostic technology. Future revenues from this license
agreement are expected to be minimal. We do not expect to generate material revenue or fee income
unless we enter into a major licensing arrangement.
Costs and expenses
The following table summarizes our operating expenses for the periods indicated, in thousands
and as a percentage of total expenses. This table also provides the changes in our operating
expense components and their percentages:
Nine Months ended September 30, | ||||||||||||||||||||||||
2008 | 2007 | Increase (Decrease) | ||||||||||||||||||||||
% of Total | % of Total | |||||||||||||||||||||||
Operating | Operating | |||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | $ | % | |||||||||||||||||||
Research and development |
$ | 13,869 | 69 | % | $ | 9,636 | 60 | % | $ | 4,233 | 44 | % | ||||||||||||
General and
administrative |
6,304 | 31 | % | 6,488 | 40 | % | (184 | ) | -3 | % | ||||||||||||||
Total operating expenses |
$ | 20,173 | 100 | % | $ | 16,124 | 100 | % | $ | 4,049 | 25 | % | ||||||||||||
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Research and development expenses
The table below summarizes the most significant components of our research and development
expenses for the periods indicated, in thousands and as a percentage of total research and
development expenses. The table also provides the changes in these components and their
percentages:
Nine Months ended September 30, | ||||||||||||||||||||||||
2008 | 2007 | Increase (Decrease) | ||||||||||||||||||||||
% of Total | % of Total | |||||||||||||||||||||||
Operating | Operating | |||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | $ | % | |||||||||||||||||||
External services |
$ | 10,202 | 73 | % | $ | 6,250 | 65 | % | $ | 3,952 | 63 | % | ||||||||||||
Employee compensation and related |
3,215 | 23 | % | 2,835 | 29 | % | 380 | 13 | % | |||||||||||||||
Stock-based compensation |
208 | 1 | % | 297 | 3 | % | (89 | ) | -30 | % | ||||||||||||||
Other |
244 | 2 | % | 254 | 3 | % | (10 | ) | -4 | % | ||||||||||||||
Total research and development |
$ | 13,869 | 100 | % | $ | 9,636 | 100 | % | $ | 4,233 | 44 | % | ||||||||||||
The most significant increase in research and development expenses for the nine month
period ended September 30, 2008, as compared to the nine months ended September 30, 2007, of
$4,233,000 is due to an increase in external service costs incurred on our clinical development
programs. Most notably, we experienced increases in external service costs on our Anaplastic
Thyroid Cancer study, our Non-Small Cell Lung Cancer study and our Ovarian Cancer study totaling
$4,651,000. This was partially offset by a decrease of $530,000 in our study of solid tumors in
combination with Bevacizumab. The increase in external services expenses were accompanied by an
increase in employee compensation and related costs required to manage these ongoing studies. We
expect this trend of increases in research and development expenses to continue for the foreseeable
future as we anticipate the continued development of our potential product candidates.
General and administrative expenses
The table below summarizes the most significant components of our general and
administrative expenses for the periods indicated, in thousands and as a percentage of total
general and administrative expenses. The table also provides the changes in these components and
their percentages:
Nine Months ended September 30, | ||||||||||||||||||||||||
2008 | 2007 | Increase (Decrease) | ||||||||||||||||||||||
% of Total | % of Total | |||||||||||||||||||||||
Operating | Operating | |||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | $ | % | |||||||||||||||||||
Employee compensation and related |
$ | 1,772 | 28 | % | $ | 1,932 | 30 | % | $ | (160 | ) | -8 | % | |||||||||||
Stock-based compensation |
952 | 15 | % | 1,390 | 21 | % | $ | (438 | ) | -32 | % | |||||||||||||
Consulting and professional services |
2,311 | 37 | % | 1,802 | 28 | % | $ | 509 | 28 | % | ||||||||||||||
Facilities related |
476 | 8 | % | 452 | 7 | % | $ | 24 | 5 | % | ||||||||||||||
Other |
793 | 13 | % | 912 | 14 | % | $ | (119 | ) | -13 | % | |||||||||||||
Total general and administrative |
$ | 6,304 | 100 | % | $ | 6,488 | 100 | % | $ | (184 | ) | -3 | % | |||||||||||
Decreases in employee compensation, stock-based compensation, and other expenses totaling
$717,000 for the nine months ended September 30, 2008, as compared to the nine months ended
September 30, 2007, were partially offset by an increase in consulting and professional services
expenses of $509,000. The decreases in employee compensation and related expenses and stock-based
compensation expense totaling $598,000 are primarily attributable to one-time charges in the 2007
nine-month period in connection with our former Chief Executive Officers compensation
arrangements. The decrease in other expenses of $119,000 is due to reductions in a number of
miscellaneous spending categories. The increase in consulting and professional services expenses
resulted from increases in our contracted services costs to assist in the administration of our
ongoing potential product development costs and costs of legal services. We anticipate increased
general and administrative costs as we continue to prepare for and manage activities for both
current and anticipated development programs.
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Three Months Ended September 30, 2008 and 2007
Revenue
We reported $13,000 and $0 in license revenue for the three months ended September 30, 2008
and 2007, respectively.
Costs and expenses
The following table summarizes our operating expenses for the periods indicated, in thousands
and as a percentage of total expenses. This table also provides the changes in our operating
components and their percentages:
Three Months ended September 30, | ||||||||||||||||||||||||
2008 | 2007 | Increase (Decrease) | ||||||||||||||||||||||
% of Total | % of Total | |||||||||||||||||||||||
Operating | Operating | |||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | $ | % | |||||||||||||||||||
Research and development |
$ | 5,004 | 69 | % | $ | 3,745 | 65 | % | $ | 1,259 | 34 | % | ||||||||||||
General and administrative |
2,234 | 31 | % | 1,984 | 35 | % | 250 | 13 | % | |||||||||||||||
Total operating expenses |
$ | 7,238 | 100 | % | $ | 5,729 | 100 | % | $ | 1,510 | 26 | % | ||||||||||||
Research and development expenses
The table below summarizes the most significant components of our research and development
expenses for the periods indicated, in thousands and as a percentage of total research and
development expenses. The table also provides the changes in these components and their
percentages:
Three Months ended September 30, | ||||||||||||||||||||||||
2008 | 2007 | |||||||||||||||||||||||
% of Total | % of Total | |||||||||||||||||||||||
Operating | Operating | Increase (Decrease) | ||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | $ | % | |||||||||||||||||||
External services |
$ | 3,592 | 72 | % | $ | 2,373 | 63 | % | $ | 1,219 | 51 | % | ||||||||||||
Employee compensation and related |
1,275 | 25 | % | 1,153 | 31 | % | 122 | 11 | % | |||||||||||||||
Stock-based compensation |
50 | 1 | % | 145 | 4 | % | (95 | ) | -66 | % | ||||||||||||||
Other |
87 | 2 | % | 74 | 2 | % | 13 | 18 | % | |||||||||||||||
Total research and development |
$ | 5,004 | 100 | % | $ | 3,745 | 100 | % | $ | 1,259 | 34 | % | ||||||||||||
The increase in research and development expenses for the three months ended September 30,
2008 from the comparable period in 2007 of $1,259,000 is primarily due to an increase in external
service costs incurred in connection with our clinical development programs. Most notably, we
experienced increases in external service costs related to our Anaplastic Thyroid Cancer study and,
our Non-Small Cell Lung Cancer study totaling $1,516,000. This increase was partially offset by a
decrease of $406,000 in our study of solid tumors in combination with Bevacizumab. The increase in
external services expenses was accompanied by an increase in employee compensation and related
costs of manage these ongoing studies.
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Table of Contents
General and administrative expenses
The table below summarizes the most significant components of our general and
administrative expenses for the periods indicated, in thousands and as a percentage of total
general and administrative expenses. The table also provides the changes in these components and
their percentages:
Three Months ended September 30, | ||||||||||||||||||||||||
2008 | 2007 | Increase (Decrease) | ||||||||||||||||||||||
% of Total | % of Total | |||||||||||||||||||||||
Operating | Operating | |||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | $ | % | |||||||||||||||||||
Employee compensation and related |
$ | 362 | 16 | % | $ | 412 | 21 | % | (50 | ) | -12 | % | ||||||||||||
Stock-based compensation |
401 | 18 | % | 441 | 22 | % | (40 | ) | -9 | % | ||||||||||||||
Consulting and professional services |
864 | 39 | % | 675 | 34 | % | 189 | 28 | % | |||||||||||||||
Facilities related |
251 | 11 | % | 139 | 7 | % | 112 | 81 | % | |||||||||||||||
Other |
356 | 16 | % | 317 | 16 | % | 39 | 12 | % | |||||||||||||||
Total general and administrative |
$ | 2,234 | 100 | % | $ | 1,984 | 100 | % | 250 | 13 | % | |||||||||||||
The two most significant factors in the overall increase in general and administrative
expenses in the three- month period ended September 30, 2008 in comparison to the three- month
period ended September 30, 2007 were increases in consulting and professional services and
facilities- related costs totaling $301,000. The increase in consulting and professional services
costs is attributable to increases in our contracted services costs to assist in the administration
of our ongoing potential product development costs and costs of legal services. The increase in
our facilities- related costs is attributable to the expansion of our San Bruno, California office
space in support of the continued development of our potential product candidates.
Liquidity and Capital Resources
We have experienced net losses and negative cash flow from operations each year since our
inception, except in fiscal 2000. As of September 30, 2008, we had an accumulated deficit of
approximately $157,401,000. We expect to continue to incur expenses, resulting in operating losses,
over the next several years due to, among other factors, our continuing clinical trials, planned
future clinical trials, and other anticipated research and development activities. Our cash, cash
equivalents and available-for-sale securities balance was approximately $11,085,000 at
September 30, 2008, compared to approximately $28,438,000 at December 31, 2007.
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The following table summarizes our cash flow activities for the period indicated, in
thousands:
Nine Months Ended | ||||
September 30, 2008 | ||||
Operating activities: |
||||
Net loss |
$ | (19,601 | ) | |
Non-cash adjustments to net loss |
1,121 | |||
Changes in operating assets and liabilities |
495 | |||
Net cash used in operating activities |
(17,985 | ) | ||
Investing activities: |
||||
Net decrease in available-for-sale securities |
17,348 | |||
Purchase of furniture, fixtures and equipment |
(73 | ) | ||
Other |
111 | |||
Net cash provided by investing activities |
17,386 | |||
Financing activities: |
||||
Net proceeds from issuance of common stock |
827 | |||
Net cash provided by financing activities |
827 | |||
Increase in cash and cash equivalents |
228 | |||
Cash and cash equivalents at beginning of period |
8,527 | |||
Cash and cash equivalents at end of period |
$ | 8,755 | ||
A major component of the non-cash adjustments to net loss in the nine month period ended
September 30, 2008 is compensation expense of $1,158,000 related to the issuance of options and
restricted stock. The net increase in operating assets and liabilities is attributable to an
increase in accounts payable, accrued expenses and other payables of $1,105,000 offset by an
increase in prepaid expenses and other current assets of $610,000. The decrease in
available-for-sale securities is primarily attributable to our short-term product
development-related cash requirements.
On October 1, 2008, we entered into a series of related agreements with Symphony Capital LLC
or Symphony, Symphony ViDA, Inc. or ViDA, Symphony ViDA Holdings LLC or Holdings and related
entities, including the following:
| Purchase Option Agreement; | ||
| Research and Development Agreement; | ||
| Amended and Restated Research and Development Agreement; | ||
| Technology License Agreement; | ||
| Novated and Restated Technology License Agreement; | ||
| Confidentiality Agreement; and | ||
| Additional Funding Agreement. |
In addition, on October 1, 2008, we entered into a series of related agreements with Holdings,
including the following:
| Stock and Warrant Purchase Agreement; | ||
| Warrant to purchase up to 11,281,877 shares of OXiGENE common stock; and | ||
| Registration Rights Agreement. |
Pursuant to these agreements, Holdings has formed and capitalized ViDA, a newly formed
Delaware corporation, in order (a) to hold certain intellectual property related to two of
OXiGENEs product candidates, ZYBRESTAT for use in ophthalmologic indications and OXi4503 referred
to as the Programs, which were exclusively licensed to ViDA under the Novated and Restated
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Technology License Agreement and (b) to fund commitments in the amount of up to $25,000,000. The
funding will support pre-clinical and clinical development by OXiGENE, on behalf of ViDA, of the
Programs. Under certain circumstances, the Company may be required to commit up to $15,000,000 to
ViDA. The Company is developing a topical formulation of ZYBRESTAT for ophthalmologic diseases
and conditions, such as age-related macular degeneration, that are characterized by abnormal blood
vessel growth within the eye that results in loss of vision. The Company currently plans to
undertake a series of preclinical and clinical studies with the objective of demonstrating the
utility of a topical formulation of ZYBRESTAT in an ophthalmologic indication. OXi4503 is currently
in a Phase I clinical trial in patients with advanced solid tumors. Based on favorable results in
preclinical studies, the Company currently plans to undertake further clinical trials with OXi4503
in AML and hepatic tumors.
The Purchase Option Agreement provides for the exclusive right, but not the obligation, of
OXiGENE to repurchase both Programs by acquiring 100% of the equity of ViDA at any time between
October 2, 2009 and March 31, 2012 for an amount equal to two times the amount of capital actually
invested by Holdings in ViDA,, less certain amounts. The purchase price is payable in cash or a
combination of cash and shares of OXiGENE common stock (up to 20% of the purchase price or 10% of
the total number of shares of OXiGENE common stock outstanding at such time, whichever is less), in
OXiGENEs sole discretion, subject to certain limitations. If OXiGENE does not exercise its
exclusive right with respect to the purchase of the Programs licensed under the agreement with
ViDA, rights to the Programs at the end of the development period will remain with ViDA.
OXiGENE has issued to Holdings, pursuant to the Stock and Warrant Purchase Agreement, (1) an
aggregate of 5,835,241 shares of OXiGENE common stock (the Shares), and (2) a ten-year warrant to
purchase 11,281,877 shares of OXiGENE common stock (the Warrant) at an exercise price of $1.11
per share, the closing price of OXiGENE common stock on The NASDAQ Global Market on September 30,
2008, the day before the consummation of the Symphony transaction. OXiGENE may issue additional
shares of its common stock and warrants in the event of specified events under the Additional
Funding Agreement, the Novated and Restated Technology License Agreement and the Purchase Option
Agreement. OXiGENE has agreed to provide certain registration rights under the Securities Act of
1933, as amended (the Securities Act) with respect to the shares issued and to be issued to
Holdings
under these agreements.
The Amended and Restated Research and Development Agreement provides that the conduct of the
activities under the mutually agreed upon development plan and budget during the development period
will be undertaken primarily by OXiGENE with support from RRD International LLC, the clinical
development partner of Symphony, and provides that the development will be overseen by a
Development Committee which is comprised of six representatives, three representatives to be
designated by OXiGENE and three representatives to be designated by Holdings. The Development
Committee will report to the board of directors of ViDA, which will be comprised of John Kollins,
OXiGENEs Chief Executive Officer, two representatives of Symphony, Mark Kessel and Jeffrey S.
Edelman, and two independent board members.
In addition, OXiGENE has given Holdings the right to appoint two members to its Board of Directors.
Holdings has designated Mark Kessel and Alastair J.J. Wood M.D., both Managing Directors of
Symphony Capital LLC, as the Holdings representatives, who were appointed to the Board on October
22, 2008.
In February 2008, we entered into the CEFF with Kingsbridge, pursuant to which
Kingsbridge committed to purchase, subject to certain conditions, up to 5,708,035 shares of our
common stock or up to an aggregate of $40,000,000 during the three years from the date of the
agreement. Under the CEFF, we are able to draw down shares in tranches of up to a maximum of 3.5 %
of our closing market value at the time of the draw down or the alternative draw down amount
calculated pursuant to the Common Stock Purchase Agreement, whichever is less, subject to certain
conditions. The purchase price of these shares will be at a discount of between 5 and 12 % from the
volume weighted average price of our common stock for each of the eight trading days following the
election to sell shares. Kingsbridge is not obligated to purchase shares if the volume weighted
average price of our stock is less than $1.25 per share or 85% of the closing share price of our
stock on the trading day immediately preceding the commencement of a draw down, whichever is
higher. In connection with the CEFF, we issued a warrant to Kingsbridge to purchase 250,000 shares
of our common stock at a price of $2.74 per share exercisable beginning six months after
February 19, 2008 and for a period of five years thereafter. We have filed a registration statement
on Form S-1 to register the resale by Kingsbridge of the shares issuable to Kingsbridge under the
CEFF, which was declared effective by the SEC on May 15, 2008. In June 2008, we completed our
first drawdown under the CEFF, netting approximately $900,000.
Our anticipated cash requirement for fiscal 2008 is expected to be between $22,000,000
and $28,000,000. For the first nine months of 2008 our cash utilization from operations totaled
$17,985,000 for an average of approximately $6,000,000 per quarter. Based on our current
projections, our cash utilization for the next nine quarters is expected to increase to between
$7,000,000 and $8,000,000 per quarter. Based on these plans, we expect our currently available
cash, cash equivalents and marketable securities to meet our cash requirements into the first
quarter of fiscal 2009. Our cash utilization amount is highly dependent on the progress of our
potential product development programs, particularly the rate of recruitment of patients in our
human clinical trials, much of which is not within our control as well as the timing of hiring
development and administrative staff to support our product development plans. However, subject to
shareholder approval at a special meeting of stockholders scheduled for December 9, 2008 we
anticipate that the Warrant will be exercised for approximately $12,500,000 augmenting our cash,
cash equivalents and marketable securities balances as of September 30, 2008 of $11,085,000. Our
primary anticipated uses of funds during the remainder of fiscal 2008 and in 2009 involve the
pre-clinical and clinical development of our product candidates.
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Our cash requirements may vary materially from those now planned for or anticipated by
management due to numerous risks and uncertainties. These risks and uncertainties include, but are
not limited to: the progress of and results of our pre-clinical testing and clinical trials of our
VDAs and OQPs under development, including ZYBRESTAT, our lead compound, and OXi4503; the progress
of our research and development programs; the time and costs expended and required to obtain any
necessary or desired regulatory approvals; the resources, if any, that we devote to developing
manufacturing methods and advanced technologies; our ability to enter into licensing arrangements,
including any unanticipated licensing arrangements that may be necessary to enable us to continue
our development and clinical trial programs; the costs and expenses of filing, prosecuting and, if
necessary, enforcing our patent claims, or defending ourselves against possible claims of
infringement by us of third party patent or other technology rights; the costs of commercialization
activities and arrangements, if any, undertaken by us; and, if and when approved, the demand for
our products, which demand is dependent in turn on circumstances and uncertainties that cannot be
fully known, understood or quantified unless and until the time of approval, for example the range
of indications for which any product is granted approval.
We will require significant additional funding to remain a going concern and to fund
operations until such time, if ever, we become profitable. There can be no assurance that
additional financing will be available on acceptable terms when needed, if at all. In addition to
equity capital financing, we continue to aggressively pursue other forms of capital infusion
including strategic alliances with organizations that have capabilities and/or products that are
complementary to our own, in order to continue the development of our potential product candidates.
In the event that the capital infusion initiatives discussed above are unsuccessful and
should we be unable to obtain shareholder approval of further issuances of our common stock to
Holdings or to sell shares under the CEFF due to the limitations contained in the CEFF agreement or
our ability to maintain registration of the securities with the SEC, we are prepared to implement
cost reduction measures. These cost reduction measures may include any or all of the following
activities, which may be undertaken at any time: the cessation, reduction in scope or delay of the
current clinical trials of ZYBRESTAT and other supporting projects, the reduction and delay in
hiring of development and administrative staff, and the reduction of certain employee incentive
programs.
The following table presents our contractual obligations and commercial commitments
as of September 30, 2008, in thousands:
Less than | ||||||||||||||||||||
Total | 1 year | 1-3 years | 4-5 years | After 5 years | ||||||||||||||||
Research & Development Projects |
$ | 15,436 | $ | 10,259 | $ | 5,178 | $ | | $ | | ||||||||||
Operating Leases |
2,958 | 795 | 1,897 | 266 | | |||||||||||||||
Total contractual cash obligations |
$ | 18,394 | $ | 11,054 | $ | 7,074 | $ | 266 | | |||||||||||
Payments under our pre-clinical, product development and clinical development
contracts are based on the completion of activities as specified in the contract. The amounts in
the table above assume the successful completion by third-party contractors of all activities
contemplated in the agreements with such parties. In addition, not included in the operating leases
above is sublease income, which is expected to total approximately $337,000 for the 12-month period
ending September 30, 2009 and $326,000 during the 1-3 year period thereafter for a total of
$663,000 for the periods presented.
Our primary drug development programs are based on a series of natural products
called Combretastatins. In August 1999, we entered into an exclusive license for the commercial
development, use and sale of products or services covered by certain patent rights owned by Arizona
State University. This agreement was subsequently amended in June 2002. From the inception of the
agreement through September 30, 2008, we have paid a total of $2,500,000 in connection with this
license. The agreement provides for additional payments in connection with the license arrangement
upon the initiation of certain clinical trials or the receipt of certain regulatory approvals,
which payments could be accelerated upon the achievement of certain financial milestones, as
defined in the agreement. We have made total milestone payments of $700,000 through March 31, 2008.
In the nine months ended September 30, 2008, we did not make any payments pursuant to meeting a
financial milestone under the agreement. The license agreement also provides for additional
payments upon our election to develop certain additional compounds, as defined in the agreement.
Future milestone payments under this agreement could total up to an additional $200,000. We are
also required to pay royalties on future net sales of products associated with these patent rights.
In March 2007, we entered into an exclusive license agreement for the development
and commercialization of products covered by certain patent rights owned by Intracel Holdings,
Inc., a privately held corporation. We paid Intracel $150,000 in March 2007 as an up-front license
fee that provides us with full control over the development and commercialization of licensed
compounds and molecular products. We expensed the up-front payment to research and development
expense. The agreement provides for additional payments to Intracel based on the achievement of
certain clinical milestones and royalties based on the achievement of certain sales milestones. We
have the right to sublicense all or portions of our licensed patent rights under this agreement.
Currently, there are no plans to further develop this technology.
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Critical Accounting Policies and Significant Judgments and Estimates
Our managements discussion and analysis of our financial condition and results of
operations is based on our financial statements, which have been prepared in accordance with
accounting principles generally accepted in the United States. The preparation of these financial
statements requires us to make estimates and assumptions that affect the reported amounts of assets
and liabilities and the disclosure of contingent assets and liabilities at the date of the
financial statements, as well as the reported revenues and expenses during the reporting periods.
On an ongoing basis, we evaluate our estimates and judgments, including those related to intangible
assets. We base our estimates on historical experience and on various other factors that are
believed to be appropriate under the circumstances, the results of which form the basis for making
the judgments about the carrying value of assets and liabilities that are not readily apparent from
other sources. Actual results may differ from these estimates.
While our significant accounting policies are more fully described in Note 1 to our
consolidated financial statements included in our Annual Report on Form 10-K for the year ended
December 31, 2007 and in our notes to the financial statements set forth in Item 1 of this
Quarterly Report on Form 10-Q, we believe the following accounting policies are most critical to
aid in fully understanding and evaluating our reported financial results.
Available-for-Sale Securities
We designate our marketable securities as available-for-sale securities.
Available-for-sale securities are carried at fair value with the unrealized gains and losses, net
of tax, if any, reported as accumulated other comprehensive income (loss) in stockholders equity.
Realized gains and losses and declines in value judged to be other-than-temporary on
available-for-sale securities are included in investment income. Interest and dividends on
securities classified as available-for-sale are included in investment income.
Accrued Research and Development
We charge all research and development expenses, both internal and external costs,
to operations as incurred. External costs consist of fees paid to consultants and other outside
providers under service contracts. Costs incurred under fixed fee contracts are accrued ratably
over the contract period absent any knowledge that the services will be performed other than
ratably. Costs incurred under contracts to perform clinical trials are accrued on a
patients-treated basis consistent with the typical terms of reimbursement. Upon termination of such
contracts, we are normally only liable for costs incurred to date. As a result, accrued research
and development expenses represent our estimated contractual liability to outside service providers
at any of the relevant times.
Impairment of Long-Lived Assets
On August 2, 1999, we entered into an exclusive license for the commercial
development, use and sale of products or services covered by certain patent rights owned by Arizona
State University. The present value of the amount payable under the license agreement has been
capitalized based on a discounted cash flow model and is being amortized over the term of the
agreement (approximately 15.5 years). We review this asset for impairment whenever there are
indications of impairment based on an undiscounted net cash flow approach, in accordance with
Statement of Financial Accounting Standards No. 144, Accounting for the Impairment or Disposal of
Long-lived Assets (SFAS 144). If the undiscounted cash flows of an intangible asset are less than
the carrying value of an intangible asset, the intangible asset is written down to the discounted
cash flow value.
Stock-Based Compensation
Effective January 1, 2006, we adopted SFAS 123R, Share-Based Payment, which
requires the expense recognition of the estimated fair value of all share-based payments issued to
employees. Prior to the adoption of SFAS 123R, the estimated fair value associated with such awards
was not recorded as an expense, but rather was disclosed in a footnote to our financial statements.
The valuation of employee stock options is an inherently subjective process, since
market values are generally not available for long-term, non-transferable employee stock options.
Accordingly, an option pricing model is utilized to derive an estimated fair value. In calculating
the estimated fair value of our stock options, we used the Black-Scholes option pricing model which
requires the consideration of the following six variables for purposes of estimating fair value:
| the stock option exercise price, | ||
| the expected term of the option, | ||
| the grant date price of our common stock, which is issuable upon exercise of the option, | ||
| the expected volatility of our common stock, | ||
| the expected dividends on our common stock (we do not anticipate paying dividends in the foreseeable future), and | ||
| the risk free interest rate for the expected option term. |
Stock Option Exercise Price & Grant Date Price of our common stock The closing market price
of our common stock on the date of grant.
Expected Term The expected term of options represents the period of time for which the
options are expected to be outstanding and is based on an analysis of historical behavior of
participants over time
Expected Volatility The expected volatility is a measure of the amount by which our stock price
is expected to fluctuate during the
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term of the option granted. We determine the expected
volatility based on the historical volatility of our common stock over a period commensurate with
the options expected term.
Expected Dividends Because we have never declared or paid any cash dividends on any of our
common stock and do not expect to do so in the foreseeable future, we use an expected dividend
yield of zero to calculate the grant date fair value of a stock option.
Risk-Free Interest Rate The risk-free interest rate is the implied yield available on U.S.
Treasury issues with a remaining life consistent with the options expected term on the date of
grant.
Of the variables above, the selection of an expected term and expected stock price
volatility are the most subjective. In the nine-month period ended September 30, 2008, we granted
options to purchase 64,000 shares of our common stock valued using these assumptions. The majority
of the stock option expense recorded in the nine-month period ended September 30, 2008 relates to
continued vesting of stock options and restricted stock that were granted after January 1, 2006. In
accordance with the transition provisions of SFAS 123R, the grant date estimates of fair value
associated with prior awards, which were also calculated using the Black-Scholes option pricing
model, have not been changed. The specific valuation assumptions that were utilized for purposes of
deriving an estimate of fair value at the time that prior awards were issued are as disclosed in
our prior Annual Reports on Form 10-K, as filed with the SEC.
Upon adoption of SFAS 123R, we were also required to estimate the level of award
forfeitures expected to occur and record compensation expense only for those awards that are
ultimately expected to vest. This requirement applies to all awards that are not yet vested,
including awards granted prior to January 1, 2006. Accordingly, we performed a historical analysis
of option awards that were forfeited prior to vesting, and ultimately recorded total stock option
expense that reflected this estimated forfeiture rate. In our calculation, we segregated
participants into two distinct groups, (1) directors and officers and (2) employees, and our
estimated
forfeiture rates were calculated at 10% and 50%, respectively. This analysis will be re-evaluated
quarterly and the forfeiture rate will be adjusted as necessary. Ultimately, the actual expense
recognized over the vesting period will only be for those shares that vest.
Tax Matters
As of December 31, 2007, we had net operating loss carry-forwards of approximately
$130,685,000 for U.S. income tax purposes, which expire through 2027. Due to the degree of
uncertainty related to the ultimate use of these loss carry-forwards, we have fully reserved this
future benefit. Additionally, the future utilization of the U.S. net operating loss carry-forwards
is subject to limitations under the change in stock ownership rules of the Internal Revenue
Service.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
At September 30, 2008, we did not hold any derivative financial instruments,
commodity-based instruments or other long-term debt obligations. We have adopted an Investment
Policy and quarterly review our compliance with the Audit Committee of the Board of Directors.
The primary objectives of the Investment Policy are to preserve principal, maintain proper
liquidity to meet operating needs and maximize yields while preserving principal. As of September
30, 2008, one of our investments with par value totaling $750,000 did not meet our Investment
Policy criteria. The investment had an unrealized loss totaling approximately $204,000 in
September, 2008.
SFAS 115 requires that a company recognize in earnings all declines in fair value below the cost
basis that are considered other -than-temporary. The Company considered, among other factors, the
decline in fair value was abrupt and has not existed for an extended period of time, the financial
condition of the issuer (AIG) has the support of a significant U.S. Government bailout, the decline
in fair value was not specific to this corporate bond but to the overall market conditions as a
whole and in reviewing the debt securities that have matured in the last quarter the Company noted
investors of these debt securities received full principal payment on the respective maturity
dates. Thus, the company has decided to hold these Corporate Bonds until maturity and expects full
recovery and concluded that the fair values are appropriate.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures.
The Securities and Exchange Commission requires that, as of the end of the period
covered by this Quarterly Report on Form 10-Q, the Chief Executive Officer (CEO) and the Chief
Financial Officer (CFO) evaluate the effectiveness of the design and operation of our disclosure
controls and procedures (as defined in Rule 13a-15(e)) under the Securities Exchange Act of 1934,
as amended, or the Exchange Act, and report on the effectiveness of the design and operation of our
disclosure controls and procedures. Based upon that evaluation, our CEO and CFO concluded that our
disclosure controls and procedures were effective to provide reasonable assurance that we record,
process, summarize and report the information we must disclose in reports that we file or submit
under the Exchange Act, within the time periods specified in the SECs rules and forms.
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Changes in Internal Control.
There were no changes in our internal control over financial reporting, identified
in connection with the evaluation of such control that occurred during the last fiscal quarter,
that have materially affected, or are reasonably likely to materially affect, our internal control
over financial reporting.
Important Considerations.
The effectiveness of our disclosure controls and procedures and our internal control
over financial reporting is subject to various inherent limitations, including cost limitations,
judgments used in decision making, assumptions about the likelihood of future events, the soundness
of our systems, the possibility of human error, and the risk of fraud. Moreover, projections of any
evaluation of effectiveness to future periods are subject to the risk that controls may become
inadequate because of changes in conditions and the risk that the degree of compliance with
policies or procedures may deteriorate over time. Because of these limitations, there can be no
assurance that any system of disclosure controls and procedures or internal control over financial
reporting will be successful in preventing all errors or fraud or in making all material
information known in a timely manner to the appropriate levels of management.
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PART II OTHER INFORMATION
Item 1. Legal Proceedings
None.
Item 1A. Risk Factors
There has been one modification to the risk factors as described in our Annual Report on Form 10-K
for the year ended December 31, 2007 filed with the SEC. The modified risk factor is presented
here in its entirety.
We have a history of losses and we anticipate that we will continue to incur losses in the future.
We have experienced net losses every year since our inception and, as of September 30, 2008,
had an accumulated deficit of approximately $157,401,000. We anticipate continuing to incur
substantial additional losses over at least the next several years due to, among other factors, the
need to expend substantial amounts on our continuing clinical trials with respect to our VDA and
OQP technologies, and anticipated research and development activities and the general and
administrative expenses associated with those activities. We have not commercially introduced any
product and our potential products are in varying early stages of development and testing. Our
ability to attain profitability will depend upon our ability to develop products that are effective
and commercially viable, to obtain regulatory approval for the manufacture and sale of our products
and to license or otherwise market our products successfully. We may never achieve profitability,
and even if we do, we may not be able to sustain being profitable.
We have licensed the intellectual property rights to OXi4503 and ZYBRESTAT for ophthalmology to
ViDA pursuant to our collaboration with Symphony. The collaboration may not yield sufficient
clinical data to allow us to determine whether we should exercise our option to repurchase these
programs prior to the expiration of the development period, and even if we decide to exercise that
option, we may not have the financial resources to exercise our option in a timely manner.
On October 1, 2008, we granted an exclusive license to the intellectual property relating to
OXi4503 and ZYBRESTAT for ophthalmology in return for a commitment from Holdings to provide up to
$25 million of committed capital to advance these programs. Under certain circumstances, the
Company may be required to commit up to $15 million to ViDA. As part of the arrangement, we
received an option granting us the exclusive right, but not the obligation, to acquire the programs
at specified points in time during the term of the development period. The development programs
under the arrangement are jointly managed by ViDA and us, and we may not agree on decisions that
would enable us to develop the potential products successfully. Even if we are in agreement on the
development plans, the development efforts may not result in sufficient clinical data to allow us
to make a fully informed decision with respect to the exercise of our option. If we do not exercise
the purchase option prior to its expiration, then our rights in and with respect to the ViDA
programs will terminate, and we will no longer have rights to the programs licensed to ViDA under
the arrangement.
If we elect to exercise the purchase option, we will be required to make a substantial
payment, which at our election may be paid partially in shares of our common stock. As a result, in
order to exercise the option, we will be required to make a substantial payment of cash and
possibly issue a substantial number of shares of our common stock. We may be required to raise
funds or enter into a financing arrangement or license arrangement with one or more third parties,
or to take some combination of these measures, in order to exercise the option, even if we pay a
portion of the purchase price with our common stock. Sufficient financing or a licensing
arrangement may not be available to us on acceptable terms if and when we decide to exercise the
purchase option.
Item 2. Unregistered Sales of Equity Securities and Use of
As described above in Note 4 to our consolidated financial statements, on October 1, 2008, OXiGENE
entered into a series of related agreements with Symphony Capital LLC, or Symphony, Symphony ViDA,
Inc., or ViDA, Symphony ViDA Holdings LLC, or Holdings, and related entities, including the
following:
| Purchase Option Agreement; | ||
| Research and Development Agreement; | ||
| Amended and Restated Research and Development Agreement; | ||
| Technology License Agreement; | ||
| Novated and Restated Technology License Agreement; | ||
| Confidentiality Agreement; and | ||
| Additional Funding Agreement. |
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In addition, on October 1, 2008, OXiGENE entered into a series of related agreements with
Holdings, including the
following:
| Stock and Warrant Purchase Agreement; | ||
| Warrant to purchase up to 11,281,877 shares of OXiGENE common stock; and | ||
| Registration Rights Agreement. |
Pursuant to these agreements, Holdings has formed and capitalized ViDA, a newly formed
Delaware corporation, in order (a) to hold certain intellectual property related to two of
OXiGENEs product candidates, ZYBRESTAT for use in ophthalmologic indications and OXi4503, referred
to as the Programs, which were exclusively licensed to ViDA under the Novated and Restated
Technology License Agreement and (b) to fund commitments in the amount of up to $25 million. The
funding will support pre-clinical and clinical development by OXiGENE, on behalf of ViDA, of the
Programs. Under certain circumstances, the Company may be required to commit up to $15 million to
ViDA. The Company is developing a topical formulation of ZYBRESTAT for ophthalmologic diseases and
conditions, such as age-related macular degeneration, that are characterized by abnormal blood
vessel growth within the eye that results in loss of vision. The Company currently plans to
undertake a series of preclinical and clinical studies with the objective of demonstrating the
utility of a topical formulation of ZYBRESTAT in an ophthalmologic indication. OXi4503 is currently
in a Phase I clinical trial in patients with advanced solid tumors. Based on favorable results in
preclinical studies, the Company currently plans to undertake further clinical trials with OXi4503
in AML and hepatic tumors.
OXiGENE has issued to Holdings, pursuant to the Stock and Warrant Purchase Agreement, (1) an
aggregate of 5,835,241 shares of OXiGENE common stock (the Shares), and (2) a ten-year warrant to
purchase 11,281,877 shares of OXiGENE common stock (the Warrant) at an exercise price of $1.11
per share, the closing price of OXiGENE common stock on The NASDAQ Global Market on September 30,
2008, the day before the consummation of the Symphony transaction. OXiGENE may issue additional
shares of its common stock and warrants in the event of specified events under the Additional
Funding Agreement, the Novated and Restated Technology License Agreement and the Purchase Option
Agreement. OXiGENE has agreed to provide certain registration rights under the Securities Act of
1933, as amended (the Securities Act) with respect to the shares issued and to be issued to
Holdings under these agreements.
The Shares and the Warrant were issued to accredited investors, as such term is defined in
Rule 501 of Regulation D promulgated under the Securities Act. The Shares and Warrant have not been
registered under the Securities Act or any state securities laws. In issuing these securities,
OXiGENE relied upon Section 4(2) of the Securities Act and the rules and regulations promulgated
thereunder to conclude that this transaction is exempt from the registration requirements of the
Securities Act. Pursuant to the Registration Rights Agreement, OXiGENE has agreed to file a
registration statement for the resale of the Shares and the shares of common stock underlying the
Warrant.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Submission of Matters to a Vote of Security Holders
None.
Item 5. Other Information
None.
Item 6. Exhibits
4.1 Form of Direct Investment Warrant, dated as of October 17, 2008. Filed as an exhibit to the
Companys Amendment No. 1 to its Current Report on Form 8-K/A on October 10, 2008 and incorporated
by reference herein.
10.1 Technology License Agreement by and between the Company and Symphony ViDA Holdings LLC, dated
as of October 1, 2008.* Filed as an exhibit to the Companys Amendment No. 1 to its Current Report
on Form 8-K/A on October 10, 2008 and incorporated by reference herein.
10.2 Novated and Restated Technology License Agreement by and among the Company, Symphony ViDA,
Inc. and Symphony ViDA Holdings LLC, dated as of October 1, 2008.* Filed as an exhibit to the
Companys Amendment No. 1 to its Current Report on Form 8-K/A on October 10, 2008 and incorporated
by reference herein.
10.3 Stock and Warrant Purchase Agreement by and between the Company and Symphony ViDA Holdings
LLC, dated as of October 1, 2008.* Filed as an exhibit to the Companys Amendment No. 1 to its
Current Report on Form 8-K/A on October 10, 2008 and incorporated by reference herein.
10.4 Purchase Option Agreement by and among the Company, Symphony ViDA, Inc. and Symphony ViDA
Holdings LLC, dated as of October 1, 2008. Filed as an exhibit to the Companys Amendment No. 1 to
its Current Report on Form 8-K/A on October 10, 2008 and incorporated by reference herein.
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10.5 Registration Rights Agreement by and between the Company and Symphony ViDA Holdings LLC, dated
as of October 1, 2008. Filed as an exhibit to the Companys Amendment No. 1 to its Current Report
on Form 8-K/A on October 10, 2008 and incorporated by reference herein.
10.6 Additional Funding Agreement by and among the Company, Symphony ViDA, Inc., Symphony ViDA
Investors LLC and Symphony ViDA Holdings LLC, dated as of October 1, 2008. Filed as an exhibit to
the Companys Amendment No. 1 to its Current Report on Form 8-K/A on October 10, 2008 and
incorporated by reference herein.
10.7 Amendment No. 1 to the Stockholder Rights Agreement by and between the Company and American
Stock Transfer & Trust Company, dated as of October 1, 2008. Filed as an exhibit to the Companys
Amendment No. 1 to its Current Report on Form 8-K/A on October 10, 2008 and incorporated by
reference herein.
10.8 Form of Indemnification Agreement between the Company and its Directors. Filed as an exhibit
to the Companys Current Report on Form 8-K on October 24, 2008 and incorporated by reference
herein.
10.9 OXiGENE, Inc. Amended and Restated Director Compensation Policy. Filed as an exhibit to the
Companys Current Report on Form 8-K on October 24, 2008 and incorporated by reference herein.
10.10 Separation Agreement between the Company and Dr. Chin dated as of October 22, 2008. Filed as
an exhibit to the Companys Current Report on Form 8-K on October 24, 2008 and incorporated by
reference herein.
10.11 Amendment No. 3 to Employment Agreement by and among the Company and Mr. Citron dated as of
October 22, 2008.
Filed as an exhibit to the Companys Current Report on Form 8-K on October 24, 2008 and
incorporated by reference herein.
31.1
|
Certification of Principal Executive Officer required by Section 302 of the Sarbanes-Oxley Act of 2002. Filed herewith. | |
31.2
|
Certification of Principal Financial Officer required by Section 302 of the Sarbanes-Oxley Act of 2002. Filed herewith. | |
32.1
|
Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. Filed herewith. |
* | Confidential treatment requested as to certain portions of the document, which portions have been omitted and filed separately with the Securities and Exchange Commission. |
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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.
OXiGENE, INC. (Registrant) |
||||
Date: November 7, 2008 | By: | /s/ John A. Kollins | ||
John A. Kollins | ||||
Chief Executive Officer | ||||
Date: November 7, 2008 | By: | /s/ James B. Murphy | ||
James B. Murphy | ||||
Vice President and Chief Financial Officer | ||||
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EXHIBIT INDEX
Exhibit | ||
Number | Description | |
4.1
|
Form of Direct Investment Warrant, dated as of October 17, 2008. Filed as an exhibit to the Companys Amendment No. 1 to its Current Report on Form 8-K/A on October 10, 2008 and incorporated by reference herein. | |
10.1
|
Technology License Agreement by and between the Company and Symphony ViDA Holdings LLC, dated as of October 1, 2008.* Filed as an exhibit to the Companys Amendment No. 1 to its Current Report on Form 8-K/A on October 10, 2008 and incorporated by reference herein. | |
10.2
|
Novated and Restated Technology License Agreement by and among the Company, Symphony ViDA, Inc. and Symphony ViDA Holdings LLC, dated as of October 1, 2008.* Filed as an exhibit to the Companys Amendment No. 1 to its Current Report on Form 8-K/A on October 10, 2008 and incorporated by reference herein. | |
10.3
|
Stock and Warrant Purchase Agreement by and between the Company and Symphony ViDA Holdings LLC, dated as of October 1, 2008.* Filed as an exhibit to the Companys Amendment No. 1 to its Current Report on Form 8-K/A on October 10, 2008 and incorporated by reference herein. | |
10.4
|
Purchase Option Agreement by and among the Company, Symphony ViDA, Inc. and Symphony ViDA Holdings LLC, dated as of October 1, 2008. Filed as an exhibit to the Companys Amendment No. 1 to its Current Report on Form 8-K/A on October 10, 2008 and incorporated by reference herein. | |
10.5
|
Registration Rights Agreement by and between the Company and Symphony ViDA Holdings LLC, dated as of October 1, 2008. Filed as an exhibit to the Companys Amendment No. 1 to its Current Report on Form 8-K/A on October 10, 2008 and incorporated by reference herein. | |
10.6
|
Additional Funding Agreement by and among the Company, Symphony ViDA, Inc., Symphony ViDA Investors LLC and Symphony ViDA Holdings LLC, dated as of October 1, 2008. Filed as an exhibit to the Companys Amendment No. 1 to its Current Report on Form 8-K/A on October 10, 2008 and incorporated by reference herein. | |
10.7
|
Amendment No. 1 to the Stockholder Rights Agreement by and between the Company and American Stock Transfer & Trust Company, dated as of October 1, 2008. Filed as an exhibit to the Companys Amendment No. 1 to its Current Report on Form 8-K/A on October 10, 2008 and incorporated by reference herein. | |
10.8
|
Form of Indemnification Agreement between the Company and its Directors. Filed as an exhibit to the Companys Current Report on Form 8-K on October 24, 2008 and incorporated by reference herein. | |
10.9
|
OXiGENE, Inc. Amended and Restated Director Compensation Policy. Filed as an exhibit to the Companys Current Report on Form 8-K on October 24, 2008 and incorporated by reference herein. |
|
10.10
|
Separation Agreement between the Company and Dr. Chin dated as of October 22, 2008. Filed as an exhibit to the Companys Current Report on Form 8-K on October 24, 2008 and incorporated by reference herein. | |
10.11
|
Amendment No. 3 to Employment Agreement by and among the Company and Mr. Citron dated as of October 22, 2008. Filed as an exhibit to the Companys Current Report on Form 8-K on October 24, 2008 and incorporated by reference herein. | |
31.1
|
Certification of Principal Executive Officer required by Section 302 of the Sarbanes-Oxley Act of 2002. Filed herewith. |
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Exhibit | ||
Number | Description | |
31.2
|
Certification of Principal Financial Officer required by Section 302 of the Sarbanes-Oxley Act of 2002. Filed herewith. | |
32.1
|
Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. Filed herewith. |
* | Confidential treatment requested as to certain portions of the document, which portions have been omitted and filed separately with the Securities and Exchange Commission. |
30