Oncotelic Therapeutics, Inc. - Quarter Report: 2009 March (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 March 31, 2009
OR
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number: 0-21990
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 has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months
(or such shorter period that the registrant was required to submit and post such files).
Yes o 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 o | Non-accelerated filer o | Smaller reporting company þ | |||
(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 May 11, 2009, there were 46,148,326 shares of the Registrants Common Stock issued and
outstanding.
Table of Contents
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
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24 | ||||||||
24 | ||||||||
24 | ||||||||
25 | ||||||||
Ex-10.1 Office Lease Agreement, dated April 21, 2009 | ||||||||
Ex-31.1 Certification of Principal Executive Officer | ||||||||
Ex-31.2 Certification of Principal Financial Officer | ||||||||
Ex-32.1 Certification of Chief Executive Officer and Chief Financial Officer |
3
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PART IFINANCIAL INFORMATION
Item 1. Financial StatementsUnaudited
OXiGENE, Inc.
Condensed Consolidated Balance Sheets
(All amounts in thousands, except per share data)
(Unaudited)
March 31, | December 31, | |||||||
2009 | 2008 | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 12,219 | $ | 18,275 | ||||
Available-for-sale securities |
702 | 643 | ||||||
Marketable securities held by Symphony ViDA, Inc., restricted |
13,777 | 14,663 | ||||||
Prepaid expenses |
753 | 382 | ||||||
Other assets |
83 | 123 | ||||||
Total current assets |
27,534 | 34,086 | ||||||
Furniture and fixtures, equipment and leasehold improvements |
1,472 | 1,456 | ||||||
Accumulated depreciation |
(1,288 | ) | (1,255 | ) | ||||
184 | 201 | |||||||
License agreements, net of accumulated amortization of $943 and $919 at
March 31, 2009 and December 31, 2008 respectively |
557 | 581 | ||||||
Other assets |
163 | 163 | ||||||
Total assets |
$ | 28,438 | $ | 35,031 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 2,022 | $ | 1,744 | ||||
Accrued research and development |
2,961 | 3,416 | ||||||
Accrued other |
524 | 606 | ||||||
Total current liabilities |
5,507 | 5,766 | ||||||
Derivative liability |
474 | 466 | ||||||
Rent loss accrual |
49 | 60 | ||||||
Total liabilities |
6,030 | 6,292 | ||||||
Commitments and contingencies (Note 5) |
||||||||
OXiGENE, Inc. Stockholders equity: |
||||||||
Common stock, $.01 par value, 100,000 shares authorized; 46,148 shares
at March 31, 2009 and 46,293 shares at December 31, 2008 issued and
outstanding |
461 | 463 | ||||||
Additional paid-in capital |
178,344 | 178,156 | ||||||
Accumulated deficit |
(164,753 | ) | (159,202 | ) | ||||
Accumulated other comprehensive loss |
(53 | ) | (110 | ) | ||||
Total OXiGENE, Inc. stockholders equity |
13,999 | 19,307 | ||||||
Non controlling interest |
8,409 | 9,432 | ||||||
Total Equity |
22,408 | 28,739 | ||||||
Total liabilities and stockholders equity |
$ | 28,438 | $ | 35,031 | ||||
See accompanying notes.
4
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OXiGENE, Inc.
Condensed Consolidated Statements of Operations
(All amounts in thousands, except per share data)
(Unaudited)
Three months ended | ||||||||
March 31, | ||||||||
2009 | 2008 | |||||||
Operating costs and expenses: |
||||||||
Research and development |
$ | 4,668 | $ | 3,689 | ||||
General and administrative |
1,965 | 2,048 | ||||||
Total operating costs and expenses |
6,633 | 5,737 | ||||||
Loss from operations |
(6,633 | ) | (5,737 | ) | ||||
Investment income |
52 | 287 | ||||||
Change in fair value of warrants |
(8 | ) | | |||||
Other income, net |
14 | 5 | ||||||
Consolidated net loss |
$ | (6,575 | ) | $ | (5,445 | ) | ||
Net loss attributed to non controlling interest |
(1,023 | ) | | |||||
Net loss attributed to OXiGENE, Inc. |
$ | (5,552 | ) | $ | (5,445 | ) | ||
Basic and diluted net loss per share attributed to OXiGENE, Inc. common
shares |
$ | (0.12 | ) | $ | (0.19 | ) | ||
Weighted-average number of common shares outstanding |
46,008 | 28,070 |
See accompanying notes.
5
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OXiGENE, Inc.
Condensed Consolidated Statements of Cash Flows
(All amounts in thousands)
(Unaudited)
Three months ended March 31, | ||||||||
2009 | 2008 | |||||||
Operating activities: |
||||||||
Consolidated net loss |
$ | (6,575 | ) | $ | (5,445 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Change in fair value of warrants |
8 | | ||||||
Depreciation |
33 | 58 | ||||||
Amortization of license agreement |
24 | | ||||||
Rent loss accrual |
(11 | ) | (135 | ) | ||||
Stock-based compensation |
186 | 442 | ||||||
Changes in operating assets and liabilities: |
||||||||
Prepaid expenses and other current assets |
(330 | ) | (209 | ) | ||||
Accounts payable, accrued expenses and other payables |
(259 | ) | (5 | ) | ||||
Net cash used in operating activities |
(6,924 | ) | (5,294 | ) | ||||
Investing activities: |
||||||||
Purchase of available-for-sale securities |
(1 | ) | (4,016 | ) | ||||
Proceeds from sale of available-for-sale securities |
| 12,303 | ||||||
Proceeds from sale of available-for-sale securities held by Symphony ViDA, Inc. |
886 | | ||||||
Purchase of furniture, fixtures and equipment |
(17 | ) | (19 | ) | ||||
Decrease in other assets |
| 129 | ||||||
Net cash provided by investing activities |
868 | 8,397 | ||||||
Financing activities: |
||||||||
Stock acquisition costs |
| (138 | ) | |||||
Net cash used in financing activities |
| (138 | ) | |||||
Increase (decrease) in cash and cash equivalents |
(6,056 | ) | 2,965 | |||||
Cash and cash equivalents at beginning of period |
18,275 | 8,527 | ||||||
Cash and cash equivalents at end of period |
$ | 12,219 | $ | 11,492 | ||||
See accompanying notes.
6
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OXiGENE, Inc.
Notes to Condensed Consolidated Financial Statements
March 31, 2009
(Unaudited)
1. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed consolidated 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. They have
been prepared on a basis which assumes that the Company will continue as a going concern, which
contemplates the realization of assets and the satisfaction of liabilities and commitments in the
normal course of business. The financial statements 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, however, all adjustments (consisting primarily of normal
recurring accruals) considered necessary for a fair presentation have been included. Operating
results for the three months ended March 31, 2009 are not necessarily indicative of the results
that may be expected for the year ending December 31, 2009.
The balance sheet at December 31, 2008 has been derived from the audited
consolidated 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, 2008,
which can be found at www.oxigene.com.
We will need to access additional funds to support our operations to remain a going concern
past October 2009, and such funding may not be available to us on acceptable terms, or at all. If
we are unable to access additional funds when needed, we may not be able to continue development of
our product candidates or we could be required to delay, scale back or eliminate some or all of our
development programs and other operations. We may seek to access additional funds through public or
private financing, strategic partnerships or other arrangements. Any additional equity financing
may be dilutive to our current stockholders and debt financing, if available, may involve
restrictive covenants. If we access funds through collaborative or licensing arrangements, we may
be required to relinquish, on terms that are not favorable to us, rights to some of our
technologies or product candidates that we would otherwise seek to develop or commercialize
ourselves. Our failure to access capital when needed may harm our business, financial condition and
results of operations. The marketable securities held by Symphony ViDA, Inc. (Symphony ViDA) are
dedicated to fund programs licensed by OXiGENE to Symphony ViDA and are not available for general
OXiGENE purposes.
Available-for-Sale Securities
In accordance with the Companys investment policy, surplus cash may be invested
primarily in commercial paper, obligations issued by the U.S. Treasury/ federal agencies or
guaranteed by the U.S. government, money market instruments, repurchase agreements, bankers
acceptances, certificates of deposit, time deposits and bank notes. 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. Securities in an unrealized loss position that are deemed not to be
other-than-temporarily impaired, due to the Companys positive intent and ability to hold the
securities until anticipated recovery, with maturation greater than twelve months, are classified
as long-term assets.
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, and 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)
March 31, 2009 | December 31, 2008 | |||||||
Blackrock Liquidity Fund maturing in less than one year |
$ | 13,777 | $ | 14,663 | ||||
Corporate bonds maturing in less than one year |
702 | 643 | ||||||
Total available-for-sale securities |
$ | 14,479 | $ | 15,306 | ||||
The Company did not hold any long-term available-for-sale securities as of March 31,
2009 or December 31, 2008. As of March 31, 2009, one of the Companys available-for-sale
securities was in an unrealized loss position of $47,000, 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
happened abruptly, 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 the corporate bond but to
the overall condition of the market and in reviewing the debt securities that have matured in the
last quarter the Company noted that investors in these debt securities received full principal
payment on the respective maturity dates. As of May 11, 2009 the unrealized loss was
$1,200. 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.
Symphony ViDA holds its restricted marketable securities balance in a Blackrock Liquidity Fund
(Liquidity Fund) valued at $1 per share. The fund is invested in Agency and U.S. Treasury
Obligations and Repurchase Agreements. The Liquidity Fund is a type of mutual fund that is
required by law to invest in low-risk securities. These funds, historically, have relatively low
risks compared to other mutual funds and pay dividends that generally reflect short-term interest
rates. They attempt to keep their net asset value (NAV) at a constant $1.00 per share only the
yield should vary. However, the NAV of the fund may fall below $1.00 if the investments perform
poorly. While investor losses in liquidity funds have been rare, they are possible.
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 is 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. |
The following table summarizes our assets that were measured at fair value as of March 31, 2009 (in
thousands):
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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) | March 31, 2009 | |||||||||||||
Cash Equivalents |
||||||||||||||||
Marketable
Securities |
$ | 13,777 | $ | | $ | | $ | 13,777 | ||||||||
Money Market Fund |
4,014 | | | 4,014 | ||||||||||||
Total Cash
Equivalents |
17,791 | | | 17,791 | ||||||||||||
Available for Sale |
||||||||||||||||
Corporate Bonds |
| 702 | | 702 | ||||||||||||
Total |
$ | 17,791 | $ | 702 | $ | | $ | 18,493 | ||||||||
The marketable securities of $13,777,000 are held by Symphony ViDA, Inc. OXiGENEs cash of $8,205,000 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 expensed 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 particular point
in time.
Net Loss Per Share
Basic and diluted net loss per share were 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 3,508,000 and 3,028,000 at March 31, 2009 and
2008, respectively, were excluded from the calculation of diluted weighted average shares outstanding.
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 periods prior to the adoption of
SFAS 123R, the Company had elected to follow Accounting Principles Board Opinion No. 25,
Accounting for Stock Issued to Employees (APB 25), and related interpretations in accounting for
share-based payments. The Company had elected the disclosure-only alternative under Statement of
Financial Accounting Standards No. 123, Accounting for
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Stock-Based Compensation (SFAS 123).
Accordingly, when options granted to employees had an exercise price equal to the market value of
the stock on the date of grant, no compensation expense was recognized. The Company adopted SFAS
123R under the modified prospective method. Under this method, beginning January 1, 2006, the
Company recognizes compensation cost for all share-based payments to employees (1) granted prior to
but not yet vested as of January 1, 2006 based on the grant date fair value determined under the
provisions of SFAS 123 and (2) granted or modified subsequent to January 1, 2006 based on the grant
date estimate of fair value determined under SFAS 123R for those awards. Prior period financial
information has not been restated.
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
months ended March 31, 2009 and 2008, options to purchase 970,000 and 24,000 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 $0.65 and $1.90 per share, respectively,
for the three months ended March 31, 2009 and 2008.
The Company granted options to purchase 100,000 shares of its common stock on April 30, 2007
to its, then Chief Business Officer, now its Chief Executive Officer, at an exercise price of $4.69
per share. The options were valued using the Black-Scholes option pricing model with the
assumptions consistent with other options granted by the Company. These options shall vest upon
execution of a major outlicensing deal, approved by the Board of Directors for the rights to one of
the Companys drug candidates. Other criteria outlined in the Chief Executive Officers employment
agreement must also be met. At this time the Company has determined that meeting the milestone is
not probable and therefore no compensation expense has been recorded for these options.
The fair values for the employee stock options were estimated at the date of grant using the
Black-Scholes option pricing model with the following weighted-average assumptions for the three
months ended March 31, 2009 and 2008:
Three months ended | Three months ended | |||||||
Weighted Average Assumptions | March 31, 2009 | March 31, 2008 | ||||||
Risk-free interest rate |
1.75 | % | 2.75 | % | ||||
Expected life |
5 years | 5 years | ||||||
Expected volatility |
55 | % | 74 | % | ||||
Dividend yield |
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 three months ended March 31, 2009:
Weighted | ||||||||||||||||
Weighted | Average | |||||||||||||||
Average | Remaining | Aggregate | ||||||||||||||
Exercise | Contractual | Intrinsic | ||||||||||||||
Shares | Price | Life | Value | |||||||||||||
(In thousands) | (Years) | (In thousands) | ||||||||||||||
Options outstanding at December 31, 2008 |
2,333 | $ | 5.01 | 6.15 | $ | | ||||||||||
Granted |
970 | $ | 0.65 | | 32 | |||||||||||
Exercised |
| | | |||||||||||||
Forfeited |
(185 | ) | $ | 4.30 | | | ||||||||||
Options outstanding at March 31, 2009 |
3,118 | $ | 3.70 | 7.34 | $ | 32 | ||||||||||
Option exercisable at March 31, 2009 |
1,328 | $ | 6.53 | 4.65 | | |||||||||||
Options vested or expected to vest at March 31, 2009 |
2,711 | $ | 4.05 | 7.04 | $ | | ||||||||||
As of March 31, 2009, there was approximately $ 996,000 of unrecognized compensation cost
related to stock option awards that is expected to be recognized as expense over a weighted average
period of 2.1 years. The total fair value of stock options that vested during the three months
ended March 31, 2009 and 2008 was approximately $64,000 and $76,000, respectively.
Non-Vested Stock
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The following table summarizes the activity for unvested stock in connection with restricted common
stock grants during the three months ended March 31, 2009:
Weighted Average | ||||||||
Shares | Fair Value | |||||||
(In thousands) | ||||||||
Unvested at December 31, 2008 |
140 | $ | 4.56 | |||||
Granted |
| $ | | |||||
Vested |
| $ | | |||||
Forfeited |
| | ||||||
Unvested at March 31, 2009 |
140 | $ | 4.56 |
The Company recorded expense of approximately $91,000 and $196,000 related to outstanding
restricted stock awards during the three months ended March 31, 2009 and 2008, respectively.
Warrants
In February 2008, the Company issued five year warrants exercisable beginning in August 2008
to Kingsbridge Capital Limited in consideration for entering into a Committed Equity Financing
Facility (CEFF). Kingsbridge may purchase from the Company up to 250,000 shares of common stock
with an exercise price of $2.74 per share. As of March 31, 2009, there were no warrants exercised
because the Companys stock price was below the exercise price of these warrants.
Pursuant
to the Symphony collaborative agreements, 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.
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 | ||||||||
March 31, | ||||||||
(In thousands) | ||||||||
2009 | 2008 | |||||||
Consolidated net loss as reported
|
$ | (6,575 | ) | $ | (5,445 | ) | ||
Unrealized gains
|
57 | 3 | ||||||
Total comprehensive loss
|
(6,518 | ) | (5,442 | ) | ||||
Less: comprehensive loss attributable to
noncontrolling interest
|
(1,023 | ) | | |||||
Comprehensive loss attributable to OXiGENE, Inc.
|
$ | (5,495 | ) | $ | (5,442 | ) | ||
Consolidation of Variable Interest Entity (VIE)
Pursuant
to the Symphony collaborative agreements entered into in October 2008, a strategic collaboration with Symphony
Capital Partners, L.P.
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(Symphony), a private-equity firm, under which Symphony agreed to provide up
to $40,000,000 in funding to support the advancement of ZYBRESTAT for oncology, ZYBRESTAT for
ophthalmology and OXi4503. Under this collaboration, we entered into a series of related agreements
with Symphony Capital LLC, Symphony ViDA, Inc., or ViDA, Symphony ViDA Holdings LLC, or Holdings.
Pursuant to these agreements, Holdings has formed and capitalized ViDA, a 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 of up to $25,000,000. The funding will support pre-clinical and clinical
development by OXiGENE, on behalf of ViDA, for ZYBRESTAT for ophthalmology and OXi4503. Under
certain circumstances, the Company may be required to commit up to $15,000,000 to ViDA. The
Companys requirement to provide additional funding for the programs will be determined by a
number of factors, including but not limited to, if at all, the determination of the need for more
funding and the written recommendation of the Joint Development Committee (JDC), the approval of
the Symphony ViDA Board, the probability and amount of the additional funding provided by Holdings,
if any, the probability that OXiGENE may provide optional funding (Optional Company Funding), and
the timing of meeting the potential obligations.
Pursuant to the agreements, OXiGENE continues to be primarily responsible for all pre-clinical
and clinical development efforts as well as maintenance of the intellectual property portfolio for
ZYBRESTAT for ophthalmology and OXi4503. OXiGENE and ViDA have established a development committee
to oversee ZYBRESTAT for ophthalmology and OXi4503. The Company has incurred and may continue to
incur expenses related to ZYBRESTAT for ophthalmology and OXi4503 that are not funded by ViDA.
OXiGENE has the exclusive right, but not the obligation, 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 Symphony 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), in the Companys sole discretion, subject to certain
limitations. If OXiGENE does not exercise its exclusive right with respect to the purchase of
ZYBRESTAT for ophthalmology and OXi4503 licensed under the agreement with ViDA, rights to ZYBRESTAT
for ophthalmology and OXi4503 at the end of the development period will remain with ViDA.
The Company has consolidated the financial position and results of operations of ViDA in
accordance with FASB Interpretation No. 46 (FIN 46R) Consolidation of Variable Interest Entities.
OXiGENE believes ViDA is by design a VIE because OXIGENE has a purchase option to acquire its
outstanding voting stock at prices that are fixed based upon the date the option is exercised. The
fixed nature of the purchase option price limits Symphonys returns, as the investor in ViDA.
Further, due to the direct investment from Holdings in OXiGENE common stock, as a related party
ViDA is a VIE of which OXiGENE is the primary beneficiary.
Symphony will be required to absorb the development risk for its equity investment in ViDA.
Pursuant to FIN 46Rs requirements, Symphonys equity investment in ViDA is classified as
noncontrolling interest in OXiGENEs consolidated balance sheet. The noncontrolling interest held
by Symphony has been reduced by the $4,000,000 fair value of the common stock it received in
consideration for the Purchase Option and the pro rata portion of the structure fees paid to
Symphony of $1,750,000 upon the transactions closing as the total consideration provided by the
Company reduces Symphonys at-risk equity investment in ViDA. While OXiGENE performs the research
and development on behalf of ViDA, our development risk is limited to the consideration we provided
to Symphony (the common stock and fees).
One
hundred percent of the
losses incurred by ViDA are charged to the noncontrolling interest, as
OXiGENE does not have any voting rights in ViDA. For the quarter ended
March 31, 2009 net losses incurred by ViDA and charged to the noncontrolling interest were
$1,023,000. At March 31, 2009, the noncontrolling interest balance was $8,409,000. As of
March 31, 2009, the Liquidity Fund held by ViDA was $13,777,000, which OXiGENE currently expects to
finance the ViDA programs through the first quarter of 2010. As noted above, OXiGENE agreements
with Symphony provide for additional funding commitments by both Symphony and the Company, subject
to certain conditions.
Accounting and Reporting of Noncontrolling Interests
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 principally requires that
earnings or losses attributed to the noncontrolling interests be reported as part of consolidated
earnings and not as a separate component of income or expense, to be included in the consolidated
statement of operations. SFAS 160 also changes the accounting for noncontrolling interests in
consolidated financial statements including the requirements to classify noncontrolling interests
as a component of stockholders equity. Accordingly, the Company has reported the consolidated
earnings in the consolidated statement of operations and reclassified the noncontrolling interest
from a mezzanine section of the balance sheet to stockholders equity.
Accounting for Derivative Financial Instruments Indexed to and Potentially Settled in the Companys
Common Stock
In connection with the strategic collaboration with Symphony in October 2008, OXiGENE agreed
that should the
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development committee of ViDA determine that ViDA needs additional funding and
that funding is provided by Holdings, the Company would issue to Holdings shares of its common
stock having a value of up to $1,000,000 (the Additional Investment Shares) on the date of
issuance. This obligation to issue the Additional Investment Shares expires no later than the term
of the strategic collaboration or March 31, 2012. The number of shares required to meet this
obligation will be based on the closing price of OXiGENE common stock on the NASDAQ Global Market
on the additional closing date. Because the closing price of the Companys common stock as of the
additional closing date is not yet determinable, the number of potential shares issuable to
Holdings to satisfy this $1,000,000 Additional Investment Shares obligation is not yet known, and
depending on the Companys stock price, there is a possibility that the number of shares necessary
to settle the Additional Investment Shares obligation may be greater than the number of shares that
OXiGENE currently has authorized.
In connection with the Committed Equity Financing Facility (CEFF) with Kingsbridge Capital
Limited , OXiGENE issued a warrant (the CEFF Warrant) to Kingsbridge Capital to purchase 250,000
shares of its common stock at a price of $2.74 per share exercisable beginning August 19, 2008 for
a period of five years thereafter, or until August 19, 2013.
Due to the indeterminable number of shares required to meet the $1,000,000 Additional
Investment Shares obligation the Company has determined that there is a possibility it may not have
sufficient authorized shares to settle its outstanding financial instruments. Pursuant to
Emerging Issues Task Force No. 00-19, Accounting for Derivative Financial Instruments Indexed to
and Potentially Settled in, a Companys Own Stock (EITF 00-19), the Companys policy with regard
to settling outstanding financial instruments is to settle those with the earliest maturity date
first, which essentially sets the order of preference for settling the awards. In accordance with
FASB Interpretation No. 133, Accounting for Derivative Instruments and Hedging Activities (FASB
133) and EITF 00-19, OXiGENE accounts for the Additional Investment Shares and CEFF Warrant
(collectively the Derivative Instruments) as liabilities. The Company began the treatment of
these Derivative Instruments as liabilities (collectively the Derivative Liabilities) as of
October 17, 2008, the initial funding and effective date of the Symphony transaction.
Establishing the value of these Derivative Instruments is an inherently subjective process. The
value of the CEFF Warrant is determined using the Black-Scholes option model. The value of the
Additional Investment Shares is determined by considering a number of factors, including among
others, the probability and amount of the additional funding provided by Holdings, if any, the
probability that OXiGENE may provide the additional funding amount, and the timing of meeting the
potential obligation. Differences in value from one measurement date to another are recorded as
other income/expense in OXiGENEs statement of operations.
As of March 31, 2009, the Company remeasured the fair value of the Derivative Liabilities to
$474,000 resulting in a loss of $8,000 for the first quarter of 2009.
2. License agreements
In August 1999, the Company entered into an exclusive license agreement for the
commercial development, use and sale of products or services covered by certain patent rights owned
by Arizona State University. From the inception of the agreement through March 31, 2008, the
Company has paid a total of $2,500,000 in connection with this license. The Company capitalized the
net present value of the total amount paid under the initial terms of the license, or $1,500,000,
and is amortizing this amount over the patent life or 15.5 years. In June 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 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 March 31,
2009, additional accelerated milestones that have previously been expensed and paid due to
achievement of certain financial milestones, totaled $700,000, and future milestones 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 of milestones defined in the agreement.
The Company is also required to pay royalties on future net sales of products associated with these
patent rights.
In October 2008, the Company announced a strategic collaboration with Symphony Capital
Partners, L.P. a private-equity firm, under which Symphony agreed to provide up to $40,000,000 in funding to support
the advancement of ZYBRESTAT for oncology, ZYBRESTAT for ophthalmology and OXi4503. Under this
collaboration, the Company entered into a series of related agreements. See Consolidation of
Variable Interest Entity above for more details.
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 next three years from the date of the agreement. Under
the CEFF, the Company is able to draw down 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
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Stock Purchase Agreement dated February 19, 2008, 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 August 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 at the date of issue,
which was recorded as contra-equity within additional paid in capital.
As part of the CEFF, the Company entered into a Registration Rights Agreement dated February
19, 2008. Pursuant to the agreement, the Company has filed a Registration Statement on Form S-1
(File No. 333-150595) with respect to the resale of the shares of common stock issuable under the
CEFF and the warrant The Registration Rights Agreement provides for payments by the Company to
Kingsbridge in the event of (1) failure to maintain effectiveness of Registration Statement in
certain circumstances, and (2) deferral or suspension of registration during black-out periods,
subject to certain exceptions. This Registration Statement is not currently usable by Kingsbridge
pending the updating of the filing by the Company to include financial statements for the fiscal
year ended December 31, 2008.
4. Recent Accounting Pronouncements
In December 2007, the FASB issued 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.
5. Subsequent Events
In April 2009, the Company executed a lease for 3,891 square feet of office space located in
Waltham, Massachusetts. The lease is for a period of two years commencing on June 1, 2009. Annual
rent payments under the lease will be $73,929 and $77,820 in the first and second year,
respectively.
Effective as of April 29, 2009, Patricia Ann Walicke, M.D., Ph.D., resigned from her position
of Vice President and Chief Medical Officer of OXiGENE, Inc. to pursue her interests in
neuroscience and immunology. The Company has initiated recruitment of a permanent replacement for
Dr. Walicke, and has retained a consultant to advise the Company on an interim basis regarding its
clinical trials and related matters.
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 March 31, 2009 and March 31, 2008 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, 2008, 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 disable and destroy
abnormal blood vessels that provide solid tumors a means of growth and survival and also are
associated with visual impairment in a number of ophthalmological diseases and conditions.
Approximately 375-400 subjects have been treated to date with ZYBRESTAT in human clinical trials.
In light of the significant human experience with ZYBRESTAT to date, and because our VDA product
candidates act via a validated therapeutic mechanism, inhibition of blood flow to tumors and to
neovascular lesions within the eye, we believe the risk associated with our drug development
programs is relatively low as compared with compounds that act via unproven or unknown mechanisms
of action.
Our most advanced therapeutic product candidate, ZYBRESTAT (USAN name fosbretabulin,
previously known as combretastatin A4 phosphate or CA4P), is currently being evaluated in a Phase
II/III pivotal registration study, which we refer to as the FACT Trial, as a potential treatment
for anaplastic thyroid cancer (ATC), a highly aggressive and lethal malignancy
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for which there are
currently no approved therapeutics and extremely limited treatment options. In 2007, we completed a
Special Protocol Assessment process with the U.S. Food and Drug Administration (FDA) for this
pivotal registration study. The FDA has also granted Fast Track designation to ZYBRESTAT for the
treatment of regionally advanced and/or metastatic ATC. In addition, ZYBRESTAT was awarded orphan
drug status by the FDA and the European Commission in the European Union for the treatment of
advanced ATC and for the treatment of medullary, Stage IV papillary and Stage IV follicular thyroid
cancers.
ZYBRESTAT is also 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, which we refer to as the
FALCON Trial; and (ii) platinum-resistant ovarian cancer in combination with carboplatin and
paclitaxel. We anticipate that results from the ongoing ZYBRESTAT Phase II ovarian cancer study
will be reported in the first half of 2009 at the annual meeting of the American Society of
Clinical Oncology (ASCO).
We believe that the ongoing FACT trial in ATC, if successful, will provide a basis for us to
seek marketing approval of ZYBRESTAT in ATC, and that the FACT rial and/or other ongoing ZYBRESTAT
studies will establish a compelling rationale for further development of ZYBRESTAT as a treatment
for:
(i) | other forms of recurrent, metastatic thyroid cancer; | ||
(ii) | other aggressive and difficult-to-treat malignancies; | ||
(iii) | use in combination with chemotherapy in a variety of solid tumors, particularly those in which carboplatin and/or paclitaxel chemotherapy are commonly used; and | ||
(iv) | use in combination with commonly used anti-angiogenic drugs, such as bevacizumab that act via VEGF pathway inhibition, in various solid tumor indications. |
We believe these areas for potential further development collectively represent a large
potential commercial market opportunity that includes cancers of the thyroid, ovary, kidney, liver,
head and neck, breast, lung, skin, brain, colon and rectum.
In addition, based upon pre-clinical results first published by our collaborators in the
November 2007 online issue of the journal BLOOD, as well as pre-clinical data presented in April
2009 at the annual meeting of the American Association of Cancer Research (AACR), we believe that
ZYBRESTAT and our other VDA product candidates, particularly OXi4503, may also have utility in the
treatment of hematological malignancies, or liquid tumors, such as acute myeloid leukemia.
In addition to developing ZYBRESTAT as an intravenously administered therapy for oncology
indications, we are undertaking, in conjunction with Symphony,an ophthalmology research and
development program with ZYBRESTAT, the objective of which is to develop a topical formulation of
ZYBRESTAT for ophthalmological diseases and conditions that are characterized by abnormal blood
vessel growth within the eye that results in loss of vision. We believe that a safe, effective and
convenient topically-administered anti-vascular therapeutic would have advantages over currently
approved anti-vascular, ophthalmological therapeutics, which must be injected directly into
patients eyes, in some cases on a chronic monthly basis. The Company is currently conducting
pre-clinical studies and plans to initiate in the first half of 2009 one human clinical trial with
intravenously-administered ZYBRESTAT to (i) confirm the therapeutic utility of ZYBRESTAT in an
ophthalmologic indication; (ii) determine blood concentrations of drug required for activity and
thereby extrapolate tissue concentrations required for activity; and (iii) further evaluate the
feasibility of and reduce the risk associated with developing a topical formulation of ZYBRESTAT
for ophthalmological indications. To date, the Company has completed pre-clinical experiments
demonstrating that ZYBRESTAT has activity in six different pre-clinical ophthalmology models,
including a model in which ZYBRESTAT was combined with an approved anti-angiogenic drug. The
Company has also completed multiple pre-clinical studies suggesting that ZYBRESTAT, when applied
topically to the surface of the eye at doses anticipated to be tolerated and non-toxic, penetrates
to the retina and choroid in quantities that the Company believes should be more than sufficient
for
therapeutic activity. Finally, the Company has completed and reported results at the 2007
annual meeting of the Association for Research in Vision and Ophthalmology (ARVO) from a Phase II
study in patients with myopic macular degeneration in which all patients in the study met the
primary clinical endpoint of vision stabilization three months after study entry.
In conjunction with Symphony, we are currently evaluating a second-generation VDA product
candidate, OXi4503, in a Phase I clinical trial in patients with advanced solid tumors, and a Phase
Ib/IIa trial in patients with solid tumors with hepatic involvement. Based on what we believe to
be compelling preclinical study results, plan to file an IND for this product candidate and
initiate an additional Phase Ib studies beginning in the second half of 2009. In pre-clinical
studies, OXi4503 has shown potent anti-tumor activity against solid tumors and acute myeloid
leukemia models, both as a single agent and in combination with other cancer treatment
modalities.We believe that OXi4503 is differentiated from other VDAs by its dual-action activity.
In pre-clinical studies, OXi4503 has demonstrated potent vascular disrupting effects on tumor
vasculature, as well as direct cytotoxic effects on tumor cells that arise from metabolism of the
drug by oxidative enzymes, which are elevated in certain tumors and tissues, (e.g., leukemia,
hepatic tumors, and melanoma) to a cytotoxic orthoquinone chemical species.
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As described above in Item 1, Financial Statements, Consolidation of Variable Interest
Entity, in October 2008, we announced a strategic collaboration with Symphony Capital Partners,
L.P., a private-equity firm, under which Symphony agreed to provide up to $40,000,000 in funding to
support the advancement of ZYBRESTAT for oncology, ZYBRESTAT for ophthalmology and OXi4503. Under
the transaction, we granted Symphony ViDA, Inc., a newly-created drug development company,
exclusive licenses to ZYBRESTAT for use in ophthalmologic indications and OXi4503. We maintain an
exclusive option, but not the obligation, to purchase the assets of Symphony ViDA Inc.
Under a sponsored research agreement with Baylor University, we are pursuing discovery and
development of novel, small-molecule therapeutics for the treatment of cancer, including
small-molecule cathepsin-L inhibitors and hypoxia-activated VDAs. Cathepsin-L is an enzyme
involved in protein degradation and has been shown to be closely involved in the processes of
angiogenesis and metastasis. Small molecule inhibitors may have the potential to slow tumor growth
and metastasis in a manner we believe could be complementary with our VDA therapeutics. We also
believe that our hypoxia-activated VDAs could serve as line-extension products to ZYBRESTAT and/or
OXi4503.
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 others, product development, regulatory oversight and clinical testing. 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.
Our failure to successfully complete human clinical trials, develop and market products over
the next several years, or realize product revenues, continue to fund our business activities,
would materially adversely affect our business, financial condition and results of operations.
We will need to access additional funds to support our operations to remain a going concern
past October 2009, and such funding may not be available to us on acceptable terms, or at all. If
we are unable to access additional funds when needed, we may not be able to continue development of
our product candidates or we could be required to delay, scale back or eliminate some or all of our
development programs and other operations. We may seek to access additional funds through public or
private financing, strategic partnerships or other arrangements. Any additional equity financing
may be dilutive to our current stockholders and debt financing, if available, may involve
restrictive covenants. If we access funds through collaborative or licensing arrangements, we may
be required to relinquish, on terms that are not favorable to us, rights to some of our
technologies or product candidates that we would otherwise seek to develop or commercialize
ourselves. Our failure to access capital when needed may harm our business, financial condition and
results of operations. The marketable securities held by Symphony ViDA, Inc. (Symphony ViDA) are
dedicated to fund programs licensed by OXiGENE to Symphony ViDA and are not available for general
corporate purposes.
Results of Operations
Three Months Ended March 31, 2009 and 2008
Revenue
We reported no licensing revenue for the three months ended March 31, 2009 and 2008. Our only
current source of revenue is from the license to a third party of our formerly owned Nicoplex and
Thiol 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
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:
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Three Months Ended March 31, | ||||||||||||||||||||||||
2009 | 2008 | Increase (Decrease) | ||||||||||||||||||||||
% of Total | % of Total | |||||||||||||||||||||||
Operating | Operating | |||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | Amount | % | |||||||||||||||||||
Research and development |
$ | 4,668 | 70 | % | $ | 3,689 | 64 | % | $ | 979 | 27 | % | ||||||||||||
General and
administrative |
1,965 | 30 | % | 2,048 | 36 | % | (83 | ) | -4 | % | ||||||||||||||
Total operating expenses |
$ | 6,633 | 100 | % | $ | 5,737 | 100 | % | $ | 896 | 16 | % | ||||||||||||
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 March 31, | ||||||||||||||||||||||||
2009 | 2008 | Increase (Decrease) | ||||||||||||||||||||||
% of Total | % of Total | |||||||||||||||||||||||
Operating | Operating | |||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | Amount | % | |||||||||||||||||||
External services |
$ | 2,841 | 60 | % | $ | 2,485 | 67 | % | $ | 356 | 14 | % | ||||||||||||
Employee compensation and related |
1,703 | 36 | % | 1,061 | 29 | % | 642 | 60 | % | |||||||||||||||
Stock-based compensation |
58 | 1 | % | 79 | 2 | % | (21 | ) | -27 | % | ||||||||||||||
Other |
66 | 1 | % | 64 | 2 | % | 2 | 3 | % | |||||||||||||||
Total research and development |
$ | 4,668 | 100 | % | $ | 3,689 | 100 | % | $ | 979 | 27 | % | ||||||||||||
The more significant components of the increase in research and development expenses of
$979,000 for the three months ended March 31, 2009 from the comparable period in 2008 were
increased spending
for our potential product development programs with outside service
providers and contractors and our internal resources to support these
development programs. We experienced increases in all three of our
development programs offset by decreases in our discovery research
programs and general development consulting costs as we
have added more internal staff. The increase in our employee
compensation and related costs of of $642,000 (60%) reflects an
increase in the number of employee equivalents in 2009 over 2008
levels, as well as more experienced staff at higher average
compensation levels.
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:
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Three Months Ended March 31, | ||||||||||||||||||||||||
2009 | 2008 | Increase (Decrease) | ||||||||||||||||||||||
% of Total | % of Total | |||||||||||||||||||||||
Operating | Operating | |||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | Amount | % | |||||||||||||||||||
Employee compensation and related |
$ | 773 | 39 | % | $ | 856 | 42 | % | $ | (83) | -10 | % | ||||||||||||
Stock-based compensation |
128 | 7 | % | 276 | 13 | % | (148 | ) | -54 | % | ||||||||||||||
Consulting and professional services |
552 | 28 | % | 673 | 33 | % | (121 | ) | -18 | % | ||||||||||||||
Facilities and related |
364 | 19 | % | 76 | 4 | % | 288 | 378 | % | |||||||||||||||
Other |
148 | 8 | % | 167 | 8 | % | (19 | ) | -11 | % | ||||||||||||||
Total general and administrative |
$ | 1,965 | 100 | % | $ | 2,048 | 100 | % | $ | (83 | ) | -4 | % | |||||||||||
The decrease of $148,000 in stock-based compensation in the first quarter of 2009 from the
first quarter of 2008 is primarily related to the forfeiture of restricted shares and options
during the fourth quarter of 2008 and first quarter of 2009. The
decrease in consulting and professional service expenses is
attributable to decreases in Board of Director and related committee
fees and legal costs offset by increases in general corporate
contracted services costs. These decreases were partially offset by
an increase in facilities related costs of $288,000 due primarily to
the new lease we entered into in our South San Francisco, California
facility.
Liquidity and Capital Resources
To date, we have financed our operations principally through net proceeds received from
private and public equity financing and beginning in the fourth quarter 2008, from our strategic
development arrangement with Symphony. We have experienced net losses and negative cash flow from
operations each year since our inception, except in fiscal 2000. As of March 31, 2009, we had an
accumulated deficit of approximately $164,753,000. We expect to
continue to incur increased
expenses, resulting in losses, over at least the next several years due to, among other factors,
our continuing and planned clinical trials and anticipated research and development activities. We
had cash, cash equivalents and available-for-sale securities of approximately $12,219,000 at March
31, 2009. In addition, investments held by Symphony ViDA Inc. were $13,777,000 as of March 31,
2009. These investments held by Symphony ViDA, Inc. are dedicated to fund programs licensed by us
to Symphony ViDA, Inc. and are not available for general corporate purposes.
The following table summarizes our cash flow activities for the period indicated, in
thousands:
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Three Months | ||||
Ended March 31, | ||||
2009 | ||||
Operating activities: |
||||
Net loss |
$ | (6,575 | ) | |
Non-cash adjustments to net loss |
240 | |||
Changes in operating assets and liabilities |
(589 | ) | ||
Net cash used in operating activities |
(6,924 | ) | ||
Investing activities: |
||||
Net decrease in available-for-sale securities |
885 | |||
Purchase of furniture, fixtures and equipment |
(17 | ) | ||
Other |
| |||
Net cash provided by investing activities |
868 | |||
Net cash used in financing activities |
| |||
Decrease in cash and cash equivalents |
(6,056 | ) | ||
Cash and cash equivalents at beginning of period |
18,275 | |||
Cash and cash equivalents at end of period |
$ | 12,219 | ||
Non-cash adjustments to net loss in the three month period ended March 31, 2009 were due
primarily to compensation expense of $186,000 related to the issuance of options and restricted
stock. The net change in operating assets and liabilities is attributable to an increase in
prepaid expenses partially offset by a decrease in other assets totaling $330,000 and an increase
in accounts payable offset by a decrease in accrued expenses totaling $259,000. The decrease
in available for sale securities and the associated decrease in cash and cash equivalents were
primarily attributable to our short- term clinical trial needs and the cash requirements to fund
those needs.
We anticipate that our existing cash, cash equivalents and available-for-sale marketable
securities of $12,219,000 along with investment income earned thereon, which is dedicated to
provide funding for our ZYBRESTAT oncology program, will enable us to maintain our currently
planned operations for this program into the fourth quarter of 2009.
Losses incurred by ViDA in support of ZYBRESTAT for ophthalmology and OXi4503 for the quarter
ended March 31, 2009 were $1,023,000. We expect the marketable securities of $13,777,000 held
by ViDA to finance the ViDA programs through the first quarter of 2010. As noted above, our
agreements with Symphony provide for additional funding commitments by both Symphony and us,
subject to certain conditions.
Our cash utilization amount is highly dependent on the progress of our potential-product
development programs, particularly, the results of our pre-clinical projects, the cost timing and
outcomes of regulatory approvals for our product candidates, the terms and conditions of our
contracts with service providers for these programs, 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 staff to support our product development plans. At the current time, we are uncertain
whether we will be able to access our CEFF during fiscal 2009 to augment our existing capital
resources, as the current market price of our common stock is below the minimum required by our
agreement with Kingsbridge. We do intend 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.
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
VDA drug candidates under development, including ZYBRESTAT, our lead drug candidate, 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
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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 need to access additional funds to support our operations to remain a going concern
past October 2009, and such funding may not be available to us on acceptable terms, or at all. If
we are unable to access additional funds when needed, we may not be able to continue development of
our product candidates or we could be required to delay, scale back or eliminate some or all of our
development programs and other operations. We may seek to access additional funds through public or
private financing, strategic partnerships or other arrangements. Any additional equity financing
may be dilutive to our current stockholders and debt financing, if available, may involve
restrictive covenants. If we access funds through collaborative or licensing arrangements, we may
be required to relinquish, on terms that are not favorable to us, rights to some of our
technologies or product candidates that we would otherwise seek to develop or commercialize
ourselves. Our failure to access capital when needed may harm our business, financial condition and
results of operations.
The following table presents our contractual obligations and commercial commitments as of
March 31, 2009:
Less than 1 | After 5 | |||||||||||||||||||
Total | year | 1-3 years | 4-5 years | years | ||||||||||||||||
Clinical development and related committements |
$ | 9,253 | $ | 8,442 | $ | 811 | $ | | $ | | ||||||||||
Operating Leases |
3,102 | 861 | 1,712 | 529 | | |||||||||||||||
Total contractual cash obligations |
$ | 12,355 | $ | 9,303 | $ | 2,523 | $ | 529 | | |||||||||||
Payments under the 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 $279,000 for the 12-month period ending March 31,
2010, and lease payments of approximately $152,000 under a lease for our new office space in
Waltham, Massachusetts entered into in April 2009.
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 March 31, 2009, 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, 2009.
In the three months ended March 31, 2009, 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.
(Intracel), a privately held corporation. We paid Intracel $150,000 in March 2007 as an up-front
license fee that provides 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.
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
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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, 2008 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. It is our policy to evaluate all
available-for-sale securities for other-than-temporary impairment.
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). Under SFAS 144, management is required to perform an
impairment analysis of our long-lived assets if triggering events occur. We review for such
triggering events periodically and, even though triggering events such as receiving a going concern
opinion from our auditors in their report on our financial statements for the fiscal year ended
December 31, 2008, and our continuing financial losses, we have determined that there is no
impairment to this asset during the periods ended up to and including March 31, 2009. In addition,
the agreement 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 agreement. To date, no clinical trials triggering payments under the agreement have been
completed and no regulatory approvals have been obtained. We expense these payments to research
and development in the period the criteria, as defined in the agreement, are satisfied.
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. For the three -month period ended March 31, 2009, we recorded approximately $186,000
of expense, associated with share-based payments, which would not have been recorded prior to the
adoption of SFAS 123R.
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, |
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| 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 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 three-month period ended March 31, 2009, we granted options to
purchase 970,000 shares of our common stock valued using these assumptions. 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 Securities and Exchange Commission.
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.
Consolidation of Variable Interest Entity
Under FASB Interpretation No. 46 (FIN 46R), Consolidation of Variable Interest Entities, a
variable interest entity (VIE) is (1) an entity that has equity that is insufficient to permit the
entity to finance its activities without additional subordinated financial support, or (2) an
entity that has equity investors that cannot make significant decisions about the entitys
operations or that do not absorb their proportionate share of the expected losses or do not receive
the expected residual returns of the entity. FIN 46R requires a VIE to be consolidated by the party
that is deemed to be the primary beneficiary, which is the party that has exposure to a majority of
the potential variability in the VIEs outcomes. The application of FIN 46R to a given arrangement
requires significant management judgment.
Pursuant to the Symphony collaboration agreements, the Company has consolidated the financial
position and results of operations of ViDA in accordance with FIN 46R. OXiGENE believes ViDA is by
design a VIE because OXIGENE has a purchase option to acquire its outstanding voting stock at
prices that are fixed based upon the date the option is exercised. The fixed nature of the purchase
option price limits Symphonys returns, as the investor in ViDA. Further, due to the direct
investment from Holdings in OXiGENE common stock, as a related party ViDA is a VIE.
FIN 46R deems parties to be de facto agents if they cannot sell, transfer, or encumber their
interests without the prior approval of an enterprise. Symphony is considered to be a de facto
agent of the Company pursuant to this provision. Further, because OXiGENE and Symphony are a
related party group based on the direct investment in OXiGENE common stock, the Company absorbs a
majority of ViDAs variability. OXIGENE evaluated whether, pursuant to FIN 46Rs requirements, the
Company is most closely associated with ViDA and concluded the Company should consolidate ViDA
because (1) OXiGENE originally developed the technology that was licensed to ViDA, (2) OXIGENE will
continue to oversee and monitor the development program, (3) OXiGENEs employees and contractors
will continue to perform substantially all of the development work, (4) OXiGENE has the ability to
make decisions that have a significant effect on the success of ViDAs activities through the
Companys representation on the ViDA Board of Directors and Joint Development Committee,
(5) ViDAs operations are substantially similar to the Companys activities, and (6) through the
Purchase Option, OXiGENE
has the ability to meaningfully participate in the benefits of a successful development
effort.
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Symphony will be required to absorb the development risk for its equity investment in ViDA.
Pursuant to FIN 46Rs requirements, Symphonys equity investment in ViDA is classified as
noncontrolling interest in OXiGENEs consolidated balance sheet. The noncontrolling interest held
by Symphony has been reduced by the $4,000,000 fair value of the common stock it received in
consideration for the Purchase Option and the pro rata portion of the structure fees paid to
Symphony of $1,750,000 upon the transactions closing as the total consideration provided by the
Company reduces Symphonys at-risk equity investment in ViDA. While OXiGENE performs the research
and development on behalf of ViDA, our development risk is limited to the consideration we provided
to Symphony (the common stock and fees).
Tax Matters
At December 31, 2008, the Company had net operating loss carry-forwards of approximately
$155,011,000 for U.S. income tax purposes, which will begin to expire in 2020 for U.S. purposes and
state operating loss carry-forwards of $60,500,000 that will begin expiring in 2009. The future
utilization of the net operating loss carry-forwards may be subject to an annual limitation due to
ownership changes that could have occurred in the past or that may occur in the future under the
provisions of Internal Revenue Code Section 382 or 383. Realization of the deferred tax assets is
uncertain due to the historical losses of the Company and therefore a full valuation allowance has
been established.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
At March 31, 2009, we did not hold any derivative financial instruments, commodity-based
instruments or other long-term debt obligations. We account for the Symphony Additional Investment
Shares and the Kingsbridge CEFF Warrant as liabilities. As of March 31, 2009, the Additional
Investment Shares are valued at $448,000, and the Kingsbridge CEFF Warrant is valued at $26,000.
We have adopted an Investment Policy, the primary objectives of which are to preserve
principal, maintain proper liquidity to meet operating needs and maximize yields while preserving
principal. Although our investments are subject to credit risk, we follow procedures to limit the
amount of credit exposure in any single issue, issuer or type of investment. Our investments are
also subject to interest rate risk and will decrease in value if market interest rates increase.
However, due to the conservative nature of our investments and relatively short duration, we
believe that interest rate risk is mitigated. Our cash and cash equivalents are maintained in U.S.
dollar accounts. Although we conduct a number of our trials and studies outside of the United
States, we believe our exposure to foreign currency risk to be limited as the arrangements are in
jurisdictions with relatively stable currencies.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures.
The Securities and Exchange Commission, or SEC, 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.
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, which
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 IIOTHER INFORMATION
Item 1. Legal Proceedings
None.
Item 1A. Risk Factors
There have been no material changes to the risk factors as described in our Annual Report on Form
10-K for the year ended
December 31, 2008 filed with the SEC.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Submission of Matters to a Vote of Security Holders
None
Item 5. Other Information
In April 2009, the Company executed a lease for 3,891 square feet of office space located in
Waltham, Massachusetts. The lease is for a period of two years commencing on June 1, 2009. Annual
rent payments under the lease will be $73,929 and $77,820 in the first and second years,
respectively.
Item 6. Exhibits
10.1
|
Office Lease Agreement, dated April 21, 2009, between the Registrant and King Waltham LLC. | |
31.1
|
Certification of Principal Executive Officer required by Section 302 of the Sarbanes-Oxley Act of 2002. | |
31.2
|
Certification of Principal Financial Officer required by Section 302 of the Sarbanes-Oxley Act of 2002. | |
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. |
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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: May 15, 2009 | By: | /s/ John A. Kollins | ||
John A. Kollins | ||||
Chief Executive Officer | ||||
Date: May 15, 2009 | By: | /s/ James B. Murphy | ||
James B. Murphy | ||||
Vice President and Chief Financial Officer |
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EXHIBIT INDEX
Exhibit | ||
Number | Description | |
10.1
|
Office Lease Agreement, dated April 21, 2009, between the Registrant and King Waltham LLC. | |
31.1
|
Certification of Principal Executive Officer required by Section 302 of the Sarbanes-Oxley Act of 2002. | |
31.2
|
Certification of Principal Financial Officer required by Section 302 of the Sarbanes-Oxley Act of 2002. | |
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. |
26