Oncotelic Therapeutics, Inc. - Quarter Report: 2007 September (Form 10-Q)
Table of Contents
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2007
OR
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number: 0-21990
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
WALTHAM, MA 02451
(Address of principal executive offices, including zip code)
(781) 547-5900
(Registrants telephone number, including area code)
Not applicable
(Former name, former address and former fiscal year, if changed since last report)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o Accelerated filer þ Non-accelerated filer o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes o No þ
As of October 15, 2007, there were 28,504,997 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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PART IFINANCIAL INFORMATION
Item 1. Financial StatementsUnaudited
OXiGENE, Inc.
Condensed Balance Sheets
(All amounts in thousands, except per share data)
(Unaudited)
September 30, 2007 | December 31, 2006 | |||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash
equivalents |
$ | 11,828 | $ | 15,687 | ||||
Available-for-sale
securities |
21,348 | 29,661 | ||||||
Prepaid
expenses |
672 | 270 | ||||||
Other assets
|
145 | 371 | ||||||
Total current
assets |
33,993 | 45,989 | ||||||
Furniture and fixtures, equipment
and leasehold improvements |
1,333 | 1,248 | ||||||
Accumulated
depreciation |
(1,092 | ) | (1,007 | ) | ||||
241 | 241 | |||||||
Available-for-sale securities -long term |
| 491 | ||||||
License agreement, net of
accumulated amortization of $798
and $724 at September 30, 2007 and
December 31, 2006, respectively |
703 | 777 | ||||||
Deposits |
555 | 144 | ||||||
Total assets |
$ | 35,492 | $ | 47,642 | ||||
Liabilities and stockholders equity |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 1,043 | $ | 683 | ||||
Accrued research and development |
2,847 | 2,603 | ||||||
Accrued other |
1,064 | 936 | ||||||
Total current liabilities |
4,954 | 4,222 | ||||||
Commitments and contingencies |
||||||||
Stockholders equity: |
||||||||
Common stock, $.01 par value,
100,000 shares authorized;
28,505 shares at September 30,
2007 and 28,175 shares at
December 31, 2006, issued and outstanding |
285 | 282 | ||||||
Additional paid-in capital |
162,253 | 160,569 | ||||||
Accumulated deficit |
(132,004 | ) | (117,412 | ) | ||||
Accumulated other
comprehensive income (loss) |
4 | (19 | ) | |||||
Total stockholders
equity |
30,538 | 43,420 | ||||||
Total liabilities and stockholders
equity |
$ | 35,492 | $ | 47,642 | ||||
See accompanying notes.
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OXiGENE, Inc.
Condensed Statements of Operations
(All amounts in thousands, except per share data)
(Unaudited)
Three months ended | Nine months ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2007 | 2006 | 2007 | 2006 | |||||||||||||
License revenue |
$ | | $ | | $ | 7 | $ | | ||||||||
Costs and expenses: |
||||||||||||||||
Research and development (1) |
3,745 | 2,738 | 9,636 | 8,333 | ||||||||||||
General and administrative (1) |
1,984 | 1,626 | 6,488 | 5,585 | ||||||||||||
Total costs and expenses |
5,729 | 4,364 | 16,124 | 13,918 | ||||||||||||
Operating loss |
(5,729 | ) | (4,364 | ) | (16,117 | ) | (13,918 | ) | ||||||||
Investment income |
467 | 642 | 1,562 | 1,892 | ||||||||||||
Other expense, net |
(13 | ) | (8 | ) | (37 | ) | (36 | ) | ||||||||
Net loss |
$ | (5,275 | ) | $ | (3,730 | ) | $ | (14,592 | ) | $ | (12,062 | ) | ||||
Basic and diluted net loss per common share |
$ | (0.19 | ) | $ | (0.14 | ) | $ | (0.52 | ) | $ | (0.44 | ) | ||||
Weighted average number of common shares outstanding |
27,938 | 27,624 | 27,896 | 27,553 | ||||||||||||
(1) Includes share-based compensation expense as follows: |
||||||||||||||||
Research and development |
$ | 145 | $ | 84 | $ | 297 | $ | 332 | ||||||||
General and administrative |
441 | 305 | 1,392 | 1,085 |
See accompanying notes.
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OXiGENE, Inc.
Condensed Statements of Cash Flows
(All amounts in thousands)
(Unaudited)
Nine months ended | ||||||||
September 30, | ||||||||
2007 | 2006 | |||||||
Operating activities: |
||||||||
Net loss |
$ | (14,592 | ) | $ | (12,062 | ) | ||
Adjustment to reconcile net loss to net cash used in operating activities: |
||||||||
Depreciation |
85 | 60 | ||||||
Stock-based compensation |
1,687 | 1,417 | ||||||
Amortization of licensing agreement |
74 | 72 | ||||||
Changes in operating assets and liabilities: |
||||||||
Prepaid expenses and other current assets |
(176 | ) | (371 | ) | ||||
Accounts payable and accrued expenses |
732 | 289 | ||||||
Net cash used in operating activities |
(12,190 | ) | (10,595 | ) | ||||
Investing activities: |
||||||||
Purchase of available-for-sale securities |
(28,321 | ) | (41,654 | ) | ||||
Proceeds from sale of available-for-sale securities |
37,148 | 39,924 | ||||||
Purchase of furniture, fixtures and equipment |
(85 | ) | (156 | ) | ||||
Deposits |
(411 | ) | 5 | |||||
Net cash provided by (used in) investing activities |
8,331 | (1,881 | ) | |||||
Financing activities: |
||||||||
Proceeds from the issuance of common stock |
| 342 | ||||||
Net cash provided by financing activities |
| 342 | ||||||
Net decrease in cash and cash equivalents |
$ | (3,859 | ) | $ | (12,134 | ) | ||
Cash and cash equivalents at beginning of period |
$ | 15,687 | $ | 32,344 | ||||
Cash and cash equivalents at end of period |
$ | 11,828 | $ | 20,210 | ||||
See accompanying notes.
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OXiGENE, Inc.
Notes to Condensed Financial Statements
September 30, 2007
(Unaudited)
1. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed financial statements have been prepared in
accordance with U.S. generally accepted accounting principles for interim financial information and
with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not
include all of the information and footnotes required by U.S. generally accepted accounting
principles for complete financial statements. In the opinion of management, all adjustments
(consisting primarily of normal recurring accruals) considered necessary for a fair presentation
have been included. Operating results for the nine months ended September 30, 2007 are not
necessarily indicative of the results that may be expected for the year ending December 31, 2007.
The balance sheet at December 31, 2006 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, 2006,
which can be found at www.oxigene.com.
Available-for-Sale Securities
In accordance with the Companys investment policy, surplus cash is invested
primarily in investment-grade corporate bonds, commercial paper, U.S. government agency debt
securities, and certificates of deposit. In accordance with Statement of Financial Accounting
Standards No. 115 (SFAS 115), Accounting for Certain Investments in Debt and Equity Securities,
the Company separately discloses cash and cash equivalents from investments in marketable
securities. The Company designates its marketable securities as available-for-sale securities.
Available-for-sale securities are carried at fair value with the unrealized gains and losses, net
of tax, if any, reported as accumulated other comprehensive income (loss) in stockholders equity.
The Company reviews the status of the unrealized gains and losses of its available-for-sale
marketable securities on a regular basis. Realized gains and losses and declines in value judged to
be other-than-temporary on available-for-sale securities are included in investment income.
Interest and dividends on securities classified as available-for-sale are included in investment
income. Securities in an unrealized loss position 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, continuously looking
for the safest, most risk-averse investments that will yield the highest rates of return in their
category.
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The following is a summary of the fair values of the Companys available-for-sale securities:
(amounts in thousands)
September 30, 2007 | December 31, 2006 | |||||||
Current |
||||||||
Government bonds and notes |
$ | | $ | 1,982 | ||||
Corporate bonds |
6,548 | 12,524 | ||||||
Subtotal bonds |
6,548 | 14,506 | ||||||
Asset-backed securities |
4,650 | | ||||||
Commercial paper |
9,150 | 11,654 | ||||||
Certificates of deposit |
1,000 | 3,501 | ||||||
Subtotal current available-for-sale securities |
$ | 21,348 | $ | 29,661 | ||||
Long Term |
||||||||
Corporate bonds |
| 491 | ||||||
Subtotal long term available-for-sale securities |
$ | | $ | 491 | ||||
Total available-for-sale securities |
$ | 21,348 | $ | 30,152 | ||||
As of September 30, 2007, the Companys available-for-sale securities are at a net
unrealized gain position totaling approximately $4,000. At December 31, 2006, the Company determined that one
floating rate note and two of its corporate bonds were judged to be other-than-temporarily impaired
by approximately $9,000 and reduced their fair values as of that date through a charge to operations. As of December 31, 2006, 13
of the Companys remaining available-for-sale securities were in an unrealized loss position,
primarily attributable to increases in short-term to medium-term interest rates over the course of
2006. The Company determined that these unrealized losses were temporary, after taking into
consideration its current cash and cash equivalent balances and its expected future cash
requirements.
Accrued Research and Development
The Company charges all research and development expenses, both internal and
external costs, to operations as incurred. The Companys research and development costs represent
expenses incurred from the engagement of outside professional service organizations, product
manufacturers and consultants associated with the development of the Companys potential product
candidates. The Company recognizes expense associated with these arrangements based on the
completion of activities as specified in the applicable contracts. Costs incurred under fixed fee
contracts are accrued ratably over the contract period absent any knowledge that the services will
be performed other than ratably. Costs incurred under contracts with clinical trial sites and
principal investigators are generally accrued on a patient-treated basis consistent with the terms
outlined in the contract. In determining costs incurred on some of these programs, the Company
takes into consideration a number of factors, including estimates and input provided by internal
program managers. Upon termination of such contracts, the Company is normally only liable for costs
incurred and committed to date. As a result, accrued research and development expenses represent
the Companys estimated contractual liability to outside service providers at any relevant time.
Net Loss Per Share
Basic and diluted net loss per share 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 2,798,000 and 2,351,000 at September 30,
2007 and 2006, respectively, were excluded from the calculation of weighted average shares for
diluted loss per share.
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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 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 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 and
nine months ended September 30, 2007, options to purchase 200,000 and 637,000 shares, respectively,
of the Companys common stock were granted. The weighted average fair values of the options granted
based on the assumptions outlined in the table below were $2.59 and $2.50 per share, respectively,
for the three and nine months ended September 30, 2007. During the nine months ended September 30,
2006, options to purchase 454,500 shares of the Companys common stock were granted with a weighted
average fair value of $2.90 per share. During the three months ended September 30, 2006, options to
purchase 260,000 shares of the Companys common stock were granted, with a weighted average fair
value of $3.03 per share.
The
Company granted options to purchase 100,000 shares of common stock on April 30, 2007 that are
subject to certain performance conditions. The Company has determined that it was not probable that
those performance conditions will be met as of September 30,
2007, therefore no compensation
expense has been recorded.
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
and nine months ended September 30, 2007 and 2006:
Three months ended | Three months ended | Nine months ended | Nine months ended | |||||||||||||
Weighted Average Assumptions | September 30, 2007 | September 30, 2006 | September 30, 2007 | September 30, 2006 | ||||||||||||
Risk-free interest rate |
4.62 | % | 4.99 | % | 4.62 | % | 5.05 | % | ||||||||
Expected life |
5 years | 5 years | 5 years | 5 years | ||||||||||||
Expected volatility |
86 | % | 95 | % | 88 | % | 95 | % | ||||||||
Dividend yield |
0.00 | % | 0.00 | % | 0.00 | % | 0.00 | % |
Options, Warrants and Non-Vested Stock
The following is a summary of the Companys stock option activity under its 1996 and 2005 Stock
Plans for the nine months ended
September 30, 2007:
Weighted | ||||||||||||||||
Average | ||||||||||||||||
Remaining | ||||||||||||||||
Shares | Weighted- | Contractual | Aggregate Intrinsic | |||||||||||||
(in | Average | Life | Value | |||||||||||||
thousands) | Exercise Price | (years) | ( in thousands) | |||||||||||||
Options outstanding at December 31, 2006 |
1,632 | $ | 6.11 | |||||||||||||
Granted |
637 | |||||||||||||||
Exercised |
| | ||||||||||||||
Forfeited/cancelled |
(178 | ) | ||||||||||||||
Options outstanding at September 30, 2007 |
2,091 | $ | 5.72 | 7.27 | $ | 161 | ||||||||||
Options exercisable at September 30, 2007 |
1,170 | $ | 6.56 | 5.90 | $ | 160 | ||||||||||
Options vested or expected to vest at September 30, 2007 |
2,022 | $ | 5.76 | 7.21 | $ | 160 |
As of September 30, 2007, there was approximately $2,393,000 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 nine months ended
September 30, 2007 and 2006 was approximately $482,000 and $498,000, respectively.
Non-Vested Stock
The following table summarizes the activity for unvested stock in connection with restricted stock
grants during the nine months ended September 30, 2007:
Shares | Weighted-Average | |||||||
(in thousands) | Fair Value | |||||||
Unvested at December 31, 2006 |
300 | $ | 5.18 | |||||
Granted |
330 | 4.63 | ||||||
Vested |
(73 | ) | 4.86 | |||||
Forfeited |
| | ||||||
Unvested at September 30, 2007 |
557 | $ | 4.90 |
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The Company recorded expense of approximately $220,000 and $764,000 related to outstanding
restricted stock awards during the three and nine months ended September 30, 2007, respectively. As
of September 30, 2007, there was approximately $1,986,000 of unrecognized compensation expense
related to restricted stock awards that will be recognized as expense over a weighted average
period of 2.2 years.
In January 2007, the Company granted 250,000 shares of restricted common stock to its Chief
Executive Officer pursuant to his employment agreement. In June 2007, the Company granted an
aggregate of 80,000 shares of restricted common stock to two new members of the Board of Directors.
The restricted stock awards were valued based on the closing price of the Companys common stock
on their respective grant dates. Compensation expense will be recognized on a straight -line basis
over the vesting period of the awards.
Warrants
In June 2003, the Company issued five-year warrants in connection with a private placement
with three large institutional investors. As of September 30, 2007, there were 150,000 of such
warrants outstanding and exercisable, which expire in June 2008. The weighted average exercise
price per share of the outstanding and exercisable warrants was $12.00 at September 30, 2007.
Comprehensive Income (Loss)
The Companys only item of other comprehensive income (loss) relates to unrealized
gains and losses on available for sale securities and is presented separately on the balance sheet, as required.
A reconciliation of comprehensive loss is as follows:
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2007 | 2006 | 2007 | 2006 | |||||||||||||
(In thousands) | ||||||||||||||||
Net loss as reported |
$ | (5,275 | ) | $ | (3,730 | ) | $ | (14,592 | ) | $ | (12,062 | ) | ||||
Unrealized gains |
18 | 64 | 23 | 50 | ||||||||||||
Comprehensive loss |
$ | (5,257 | ) | $ | (3,666 | ) | $ | (14,569 | ) | $ | (12,012 | ) | ||||
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 September 30, 2007, 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 September 30,
2007, 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 defined in the agreement. The Company is
also required to pay royalties on future net sales of products associated with these patent rights.
In March 2007, the Company entered into an exclusive license agreement for the
development and commercialization of products covered by certain patent rights owned by Intracel
Holdings, Inc., a privately held corporation. The Company paid Intracel $150,000 in March 2007 as
an up-front license fee that provides full control over the development and commercialization of
licensed compounds/molecular products. The Company expensed the up-front payment to research and
development expense. The agreement provides for additional payments by the Company to Intracel
based on the achievement of certain clinical milestones and royalties based on the achievement of
certain sales milestones. The Company has the right to sublicense all or portions of its licensed
patent rights under this agreement.
3.
Separation agreement
In September 2007, the Company entered into a separation agreement with Peter Harris M.D., its
former Chief Medical Officer. Pursuant to the separation agreement, Dr. Harris will receive
aggregate severance payments of approximately $163,000, which will be made in equal installments
through February 28, 2008. The Company also agreed to extend the expiration date of 25,000 vested
options, which will allow the exercise of those options through June 13, 2016. As a result of this
modification, the
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Company recognized additional compensation expense of $65,000 in September 2007. All
unvested options held by Dr. Harris as of September 29,
2007 were forfeited. The remaining balance of the
severance accrual is approximately $153,000 as of September 30,
2007 and is included in accrued expenses.
4. Restructuring
In August 2006, the Company implemented a restructuring plan in which it terminated
10 full-time employees, or approximately 30% of its work force. The purpose of the restructuring was primarily to streamline the clinical
development operations in order to improve the effectiveness of efforts to develop the Companys
product candidates under development.
The following table sets forth the components of the Companys restructuring as of September
30, 2007:
Amounts | ||||||||||||||||||||
Paid | Amounts | |||||||||||||||||||
Through | Accrued as of | |||||||||||||||||||
Original | Adjusted | September 30, | September 30, | |||||||||||||||||
Charges | Adjustment | Charges | 2007 | 2007 | ||||||||||||||||
General and administrative
|
||||||||||||||||||||
Employee severance and related costs |
$ | 7 | $ | | $ | 7 | $ | 7 | $ | 0 | ||||||||||
Research and development
|
||||||||||||||||||||
Employee severance and related costs |
$ | 468 | $ | 7 | $ | 475 | $ | 420 | $ | 55 | ||||||||||
Total restructuring |
$ | 475 | $ | 7 | $ | 482 | $ | 427 | $ | 55 | ||||||||||
5. Recent Accounting Pronouncements
In
June 2007, the Emerging Issues Task Force (EITF)
issued EITF 07-3 entitled
Accounting for Nonrefundable Advance Payments for Goods or Services Received for Future Research
and Development Activities. This Issue provides guidance whether nonrefundable advance payments
for goods or services that will be used or rendered for research and development activities should
be expensed when the advance payment is made or when the research and development activity has been
performed. EITF 07-3 is effective for new contracts entered into after January 1, 2008. The Company
does not expect the adoption of EITF 07-3 to have a material effect on its financial position or
results of operations.
In February 2007, the Financial Accounting Standards Board (FASB) issued Statement of
Financial Accounting Standards (SFAS) SFAS No. 159, entitled Fair Value Option for Financial
Assets and Financial Liabilities (SFAS 159). This Statement
is an amendment to SFAS No. 115,
Accounting for certain investment in debt and equity securities. SFAS 159 permits entities to
choose to measure many financial instruments and certain other items at fair value. SFAS 159 is
effective for fiscal years beginning after November 15, 2007. The Company does not expect the
adoption of SFAS 159 to have a material effect on its financial position or results of operations.
In September, 2006, the Financial Accounting Standards Board (FASB) issued Statement of
Financial Accounting Standards (SFAS) SFAS No. 157, entitled Fair Value Measurements (SFAS
157). This Statement defines fair value, establishes a framework for measuring fair value in
generally accepted accounting principles (GAAP), and expands disclosures about fair value
measurements. SFAS 157 is effective for fiscal years beginning after November 15, 2007. The
Company does not expect the adoption of SFAS 157 to have a material effect on its financial
position or results of operations.
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Our Managements Discussion and Analysis of Financial Condition and Results of Operations as
of September 30, 2007 and September 30, 2006 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, 2006, and also with the unaudited
financial statements set forth in Part 1, Item 1 of this
Quarterly Report.
Overview
We were incorporated in 1988 in the state of New York and reincorporated in 1992 in the state
of Delaware, and are a biopharmaceutical company whose primary focus is the development and
commercialization of novel small-molecule therapeutics, which we refer to as vascular disrupting
agents or VDAs, for the treatment of cancer and certain eye diseases.
Our Vascular Disrupting Agent Product Candidates
Currently, we have two VDA product candidates, ZYBRESTAT and OXi4503, in clinical
development.
ZYBRESAT (combretastatin-A4 phosphate/ CA4P) for anaplastic thyroid cancer and other oncology
indications
Our lead VDA product candidate, ZYBRESTAT , (which we previously referred to as
combrestastatin-A4 phosphate / CA4P), is
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being evaluated as a potential treatment for anaplastic
thyroid cancer in a 180-patient, multi-center, randomized, controlled, Phase II/III pivotal
registration study, which we initiated in July 2007 under a Special Protocol Assessment agreed with
the U.S. Food and Drug Administration (FDA). Anaplastic thyroid cancer is believed to be one of
the most aggressive and lethal cancers known to man, and no drugs are currently approved for the
treatment of this disease. ZYBRESTAT for anaplastic thyroid cancer has been designated as an
Orphan Drug by the FDA and the European Commission. This designation confers specific market
exclusivity benefits and tax credits. In addition, the FDA has granted us Fast Track status for
ZYBRESTAT in anaplastic thyroid cancer. In addition, ZYBRESTAT is being evaluated in multiple
ongoing clinical studies in various oncology indications, including
a study in which the safety and
efficacy of ZYBRESTAT is being evaluated in combination treatment
regimen the with antiangiongenic
drug, bevacizumab (AVASTIN®). Based on results from
preclinical and
human clinical studies, we believe antiangiongenic drugs are
potentially complementary to VDA therapy.
Development of a topical formulation of ZYBRESTAT (combretastatin-A4 phosphate/ CA4P) for
ophthalmology indications
Based on positive Phase II clinical study results observed with ZYBRESTAT in a form of macular
degeneration known as myopic macular degeneration, we believe that the product candidate has
potential utility for the treatment of age-related macular degeneration, the leading cause of
blindness in adults over 50 years of age. We are working to develop a patient-friendly and
convenient eye-drop or other topical formulation of ZYBRESTAT that can be utilized for age-related
macular degeneration and potentially other ophthalmology indications. Initial results from
preclinical formulation experiments have been positive, and we currently plan to file an
Investigational New Drug Application for the topical formulation of ZYBRESTAT as a potential
treatment for age-related macular degeneration or other
ophthalmological
indications in the first half of 2008.
OXi4503, dual-mechanism VDA for oncology indications
OXi4503, our second VDA product candidate being developed for oncology indications, is
currently being evaluated in a Phase I dose-escalation study in patients with advanced solid
tumors. We refer to OXi4503 as an ortho-quinone prodrug, and we believe that OXi4503 works via a
unique dual mechanism of action. In addition to acting as a VDA to shut down blood-flow to tumors,
we believe OXi4503 also has direct cytotoxic effects on tumors as a result of it being metabolized
to an ortho-quinone chemical structure. In preclinical studies, OXi4503 has demonstrated potent
effects as a single-agent in a variety cancer models.
How our VDA product candidates work
Our VDA candidates selectively disrupt abnormal blood vessels that solid tumors and
pathological lesions, in the case of ophthalmological diseases such as age-related macular
degeneration, depend upon for supply of oxygen and nutrients as well as removal of metabolic waste
products. Starved of critical nutrients and oxygen, the tumor or ophthalmological lesion cannot
readily progress and may die, shrink, stabilize and/or become more susceptible to treatment with
other therapeutics such as traditional chemotherapeutic drugs in the case of cancer. This general
therapeutic strategy of starving tumors or opthalmological lesions of blood supply has been
validated with the recent approval and successful commercialization of several antiangiogenic
drugs. Currently-approved antiangiogenic drugs are believed to prevent growth and development of
new blood vessels in tumors and opthalmological lesions, yet, unlike our VDA product candidates,
have minimal effects on existing blood vessels in tumors and ophthalmological lesions. Because
currently-approved anti-angiogenic drugs and our VDA product candidates work in different ways, we
believe they are likely to be complementary when used in combination to treat patients with cancer
and eye diseases. In preclinical models of cancer and eye disease, we and our collaborators have
shown that combination treatments with our VDA product candidates and antiangiogenic drugs have
additive effects as compared with single-agent therapy.
Currently, we do not have any products available for sale. The only source of potential
revenue to us at this time is from a license to a third party of our formerly owned Nicoplex and
Thiol test technology. Revenue in connection with this license arrangement is earned based on
sales of products or services utilizing this technology. We recognize revenue from this license
agreement when payments are received due to the uncertainty of the timing of sales of products or
services. Future revenues, if any, from this license agreement are expected to be minimal. We do
not expect to generate material revenue or fee income in the foreseeable future unless we enter
into a major licensing arrangement.
Our primary drug development programs are based on a series of natural products called
Combretastatins, which were originally isolated from the African bush willow tree (Combretum
caffrum) by researchers at Arizona State University, or ASU. ASU has granted us an exclusive,
worldwide, royalty-bearing license with respect to the commercial rights to particular
Combretastatins. Through in vitro and in vivo testing, it has been established that certain
Combretastatins selectively disrupt the function of newly formed abnormal blood vessels associated
with solid cancers and have a similar effect on abnormal blood vessels associated with certain
diseases of the eye. We have developed two distinct technologies that are based on Combretastatins. We are currently
developing the first of these technologies, our VDAs, for indications in both oncology and
ophthalmology. We refer to the second technology as ortho-quinone prodrugs, or OQPs. We are
currently developing OQPs for indications in oncology. We are also currently exploring
opportunities to in-license additional compounds. Our focus is on those compounds that may
complement our potential products under development or broaden solutions in our current therapeutic
areas. In addition, we continue to explore the out-licensing of some rights to certain of our
current compounds.
We are committed to a disciplined financial strategy and as such maintain a limited employee
and facilities base, with development, scientific, finance and administrative functions, which
include, among other things, product development, regulatory oversight and clinical testing,
managed from our Waltham, Massachusetts headquarters. Our research and development team members
typically work on a number of development projects concurrently. Accordingly, we do not separately
track the costs for each of these research and development projects to enable separate disclosure
of these costs on a project-by-project basis. We conduct substantial scientific activities pursuant
to collaborative
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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 to realize product revenues, would materially adversely affect our
business, financial condition and results of operations. Royalties or other revenue generated by us
from commercial sales of our potential products are not expected for several years, if at all.
We have generated a cumulative net loss of approximately $132,004,000 for the period from our
inception through September 30, 2007. We expect to incur significant additional operating losses
over at least the next several years, principally as a result of our continuing clinical trials and
anticipated research and development expenditures. The principal source of our working capital has
been the proceeds of private and public equity financings and the exercise of warrants and stock
options. We currently have no material amount of licensing or other fee income. As of September
30, 2007, we had no long-term debt or loans payable.
Results of Operations
Revenue
Nine Months Ended September 30, 2007 and 2006
We
reported $7,000 and $0 in licensing revenue for the nine months ended September 30, 2007
and 2006, respectively. As noted above our only current source of revenue is from the license to a
third party of our formerly owned nutritional and diagnostic technology. Future revenues for 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
Three Months Ended September 30, 2007 and 2006
Costs and Expenses
The following table summarizes our operating expenses for the periods indicated, in thousands and
as a percentage of total expenses:
Three Months ended September 30, | ||||||||||||||||||||||||
2007 | 2006 | Increase (Decrease) | ||||||||||||||||||||||
% of Total | % of Total | |||||||||||||||||||||||
Operating | Operating | |||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | $ | % | |||||||||||||||||||
Research and development |
$ | 3,745 | 65 | % | $ | 2,738 | 63 | % | $ | 1,007 | 37 | % | ||||||||||||
General and administrative |
1,984 | 35 | % | 1,626 | 37 | % | $ | 358 | 22 | % | ||||||||||||||
Total operating expenses |
$ | 5,729 | 100 | % | $ | 4,364 | 100 | % | $ | 1,365 | 31 | % | ||||||||||||
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:
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Three Months ended September 30, | ||||||||||||||||||||||||
2007 | 2006 | Increase (Decrease) | ||||||||||||||||||||||
% of Total | % of Total | |||||||||||||||||||||||
Operating | Operating | |||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | $ | % | |||||||||||||||||||
Employee compensation and related |
$ | 1,153 | 31 | % | $ | 1,285 | 47 | % | $ | (132 | ) | -10 | % | |||||||||||
Stock-based compensation |
145 | 4 | % | 84 | 3 | % | 61 | 73 | % | |||||||||||||||
External services |
2,373 | 63 | % | 1,274 | 47 | % | 1,099 | 86 | % | |||||||||||||||
Other |
74 | 2 | % | 95 | 3 | % | (21 | ) | -22 | % | ||||||||||||||
Total research and development |
$ | 3,745 | 100 | % | $ | 2,738 | 100 | % | $ | 1,007 | 37 | % | ||||||||||||
The most significant increase in research and development expenses from the three
months ended September 30, 2006 to the comparable period in 2007 is due to an increase in
early-stage development activities conducted with outside contractors in support of our ongoing
program initiatives. The most significant program being the ZYBRESTAT Anaplastic Thyroid Cancer
Phase II/III pivotal registration study initiated in the second quarter of 2007. The increase in
external service costs was partially offset by a decrease in employee compensation and related
expenses due to a reduction in the average number of employees dedicated to research and
development programs of approximately 39% in the third quarter of 2007 as compared to the third
quarter of 2006. The reduction in average number of employees was mainly due to the restructuring
plan implemented in August 2006, whereby 9 full time research and development employees were
terminated. We anticipate that research and development costs in total and specifically external
services costs will increase over current levels as we make progress in our ongoing clinical trial
and product development programs.
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 and provides the changes in these components and their percentages:
Three Months ended September 30, | ||||||||||||||||||||||||
2007 | 2006 | Increase (Decrease) | ||||||||||||||||||||||
% of Total | % of Total | |||||||||||||||||||||||
Operating | Operating | |||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | $ | % | |||||||||||||||||||
Employee compensation and related |
$ | 412 | 21 | % | $ | 391 | 24 | % | 21 | 5 | % | |||||||||||||
Stock-based compensation |
441 | 22 | % | 305 | 19 | % | 136 | 45 | % | |||||||||||||||
Consulting and professional services |
675 | 34 | % | 526 | 32 | % | 149 | 28 | % | |||||||||||||||
Facilities related |
139 | 7 | % | 140 | 9 | % | -1 | -1 | % | |||||||||||||||
Other |
317 | 16 | % | 264 | 16 | % | 53 | 20 | % | |||||||||||||||
Total general and administrative |
$ | 1,984 | 100 | % | $ | 1,626 | 100 | % | 358 | 22 | % | |||||||||||||
A majority of the increase in general and administrative expenses in the third quarter of 2007
over the third quarter of 2006 is related to the number of
stock-based awards being expensed. The increase in consulting and professional services in the third quarter of 2007 over the
third quarter of 2006 is related to an increase in public relations activities including retaining a
public relations consultant in 2007. We anticipate increased general and administrative costs as
we continue to prepare for and manage activities for both current and anticipated development
programs.
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Nine Months Ended September 30, 2007 and 2006
Costs and Expenses
The following table summarizes our operating expenses for the periods indicated, in thousands and
as a percentage of total expenses:
Nine Months ended September 30, | ||||||||||||||||||||||||
2007 | 2006 | Increase (Decrease) | ||||||||||||||||||||||
% of Total | % of Total | |||||||||||||||||||||||
Operating | Operating | |||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | $ | % | |||||||||||||||||||
Research and development |
$ | 9,636 | 60 | % | $ | 8,333 | 60 | % | $ | 1,303 | 16 | % | ||||||||||||
General and administrative |
6,488 | 40 | % | 5,585 | 40 | % | 903 | 16 | % | |||||||||||||||
Total operating expenses |
$ | 16,124 | 100 | % | $ | 13,918 | 100 | % | $ | 2,206 | 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:
Nine Months ended September 30, | ||||||||||||||||||||||||
2007 | 2006 | Increase (Decrease) | ||||||||||||||||||||||
% of Total | % of Total | |||||||||||||||||||||||
Operating | Operating | |||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | $ | % | |||||||||||||||||||
Employee compensation and related |
$ | 2,835 | 29 | % | $ | 3,153 | 38 | % | $ | (318 | ) | -10 | % | |||||||||||
Stock-based compensation |
297 | 3 | % | 333 | 4 | % | (36 | ) | -11 | % | ||||||||||||||
External services |
6,250 | 65 | % | 4,640 | 56 | % | 1,610 | 35 | % | |||||||||||||||
Other |
254 | 3 | % | 207 | 2 | % | 47 | 23 | % | |||||||||||||||
Total research and development |
$ | 9,636 | 100 | % | $ | 8,333 | 100 | % | $ | 1,303 | 16 | % | ||||||||||||
The most significant increase in research and development expenses from the nine months ended
September 30, 2006 to the comparable period in 2007 was driven by an increase in early
stage development activities with outside contractors in support of our ongoing program initiatives
including the initiation of the ZYBRESTAT Anaplastic Thyroid Cancer Phase II/III pivotal
registration study. The increase in external service costs was partially offset by decreases in both employee
compensation and related expenses and stock-based compensation expense, both due to a reduction in
the average number of employees dedicated to research and development programs of approximately 36%
in the first nine months of 2007 as compared to the same time period in 2006. The reduction in
average number of employees was mainly due to the restructuring plan implemented in August, 2006,
whereby 9 full time research and development employees were terminated. We anticipate that research
and development costs, particularly external services costs, will increase over current levels as
we make progress in our ongoing clinical trial and product development programs.
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 and provides the changes in these components and their percentages:
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Nine Months ended September 30, | ||||||||||||||||||||||||
2007 | 2006 | Increase (Decrease) | ||||||||||||||||||||||
% of Total | % of Total | |||||||||||||||||||||||
Operating | Operating | |||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | $ | % | |||||||||||||||||||
Employee compensation and related |
$ | 1,932 | 30 | % | 1,600 | 29 | % | $ | 332 | 21 | % | |||||||||||||
Stock-based compensation |
1,390 | 21 | % | 1,085 | 19 | % | $ | 305 | 28 | % | ||||||||||||||
Consulting and professional services |
1,802 | 28 | % | 1,631 | 29 | % | $ | 171 | 10 | % | ||||||||||||||
Facilities related |
452 | 7 | % | 380 | 7 | % | $ | 72 | 19 | % | ||||||||||||||
Other |
912 | 14 | % | 889 | 16 | % | $ | 23 | 3 | % | ||||||||||||||
Total general and administrative |
$ | 6,488 | 100 | % | $ | 5,585 | 100 | % | $ | 903 | 16 | % | ||||||||||||
A majority of the increase in general and administrative expenses in the first nine months of
2007 over the same time period in 2006 is due to increases in both employee compensation and
related expenses, as well as stock-based compensation expenses and is related to an increase in
average salaries due to the hiring of a senior officer, in
February 2007, contracted incentive compensation payment to a
senior executive, and the number of
stock-based awards being expensed. In addition, the increase in consulting and professional
services expenses is due to an addition of two members to our board of
directors as well as increases to
accounting, auditing and tax service fees. We anticipate increased general and administrative costs
as we continue to prepare for and manage activities for both current and anticipated development
programs.
Other income and expenses
Investment income decreased to approximately $467,000 in the three-month period ended
September 30, 2007 compared to $642,000 in the three-month period ended September 30, 2006.
Investment income decreased to approximately $1,562,000 in the nine-month period ended September
30, 2007 compared to approximately $1,892,000 in the nine-month period ended September 30, 2006.
These decreases are due primarily to a lower average balance of funds available for investment
during the 2007 period.
Liquidity and Capital Resources
We have experienced net losses and negative cash flow from operations each year since our
inception, except in fiscal 2000. As of September 30, 2007, we had an accumulated deficit of
approximately $132,004,000. We expect to incur expenses, resulting in operating losses, over the
next several years due to, among other factors, our continuing clinical trials, planned future
clinical trials, and other anticipated research and development activities. Our cash, cash
equivalents and available-for-sale securities balance was approximately $33,176,000 at September
30, 2007, compared to approximately $45,839,000 at December 31, 2006.
The following table summarizes our cash flow activities for the period indicated, in
thousands:
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Nine Months Ended | ||||
September 30, 2007 | ||||
Operating activities: |
||||
Net loss |
$ | (14,592 | ) | |
Non-cash adjustments to net loss |
1,846 | |||
Changes in operating assets and liabilities |
556 | |||
Net cash used in operating activities |
(12,190 | ) | ||
Investing activities: |
||||
Net purchases of available-for-sale securities |
8,827 | |||
Purchase of furniture, fixtures and equipment |
(85 | ) | ||
Deposits |
(411 | ) | ||
Net cash provided by investing activities |
8,331 | |||
Decrease in cash and cash equivalents |
(3,859 | ) | ||
Cash and cash equivalents at beginning of period |
15,687 | |||
Cash and cash equivalents at end of period |
$ | 11,828 | ||
Approximately 90% or $1,689,000, of the non-cash adjustments to net loss in the nine month
period ended September 30, 2007 is due to compensation expense related to the issuance of options
and restricted stock. The decrease in available for sale securities and the associated decrease in
cash and cash equivalents were primarily attributable to the short term clinical trial needs and
the cash requirements to fund those needs.
We anticipate that our cash, cash equivalents and available-for-sale marketable securities,
will be sufficient to satisfy the Companys projected cash requirements for most of 2008. Our intention is
to seek additional funding provided we can secure acceptable terms.
There can be no assurances that additional financing will be available
on acceptable terms. Our
primary anticipated uses of funds during the remainder of 2007 fiscal year involve the pre-clinical
and clinical development of our product candidates and potential in-licenses or other acquisitions
of technology. Our cash requirements may vary materially from those now planned for or anticipated
by management due to numerous risks and uncertainties. These risks and uncertainties include, but
are not limited to: the progress of and results of our pre-clinical testing and clinical trials of
our VDAs and OQPs under development, including ZYBRESTAT, our lead compound, and OXi4503; the
progress of our research and development programs; the time and costs expended and required to
obtain any necessary or desired regulatory approvals; the resources, if any, that we devote to
developing manufacturing methods and advanced technologies; our ability to enter into licensing
arrangements, including any unanticipated licensing arrangements that may be necessary to enable us
to continue our development and clinical trial programs; the costs and expenses of filing,
prosecuting and, if necessary, enforcing our patent claims, or defending ourselves against possible
claims of infringement by us of third party patent or other technology rights; the costs of
commercialization activities and arrangements, if any, undertaken by us; and, if and when approved,
the demand for our products, which demand is dependent in turn on circumstances and uncertainties
that cannot be fully known, understood or quantified unless and until the time of approval, for
example the range of indications for which any product is granted approval.
The following table presents our contractual obligations and commercial commitments as of
September 30, 2007:
Payments due by period
(All amounts in thousands) | ||||||||||||||||||||
Total | Less than 1 year | 1-3 years | 4-5 years | After 5 years | ||||||||||||||||
Pre-clinical, product development
and clinical development
commitments |
$ | 16,315 | $ | 11,729 | $ | 4,586 | $ | | $ | | ||||||||||
Operating leases |
1,681 | 712 | 915 | 54 | | |||||||||||||||
Total contractual cash obligations |
$ | 17,996 | $ | 12,441 | $ | 5,501 | $ | 54 | $ | | ||||||||||
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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 $197,000 for the 12-month
period ending September 30, 2008.
Our primary drug development programs are based on a series of natural products called
Combretastatins. In August 1999, we entered into an exclusive license for the commercial
development, use and sale of products or services covered by certain patent rights owned by Arizona
State University. This agreement was subsequently amended in June 2002. From the inception of the
agreement through September 30, 2007, 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 payments of $700,000 through September 30, 2007. In
the nine months ended September 30, 2007, we made a payment of $100,000 pursuant to meeting a
financial milestone under the agreement. The license agreement also provides for additional
payments upon our election to develop certain additional compounds, as defined in the agreement.
Future milestone payments under this agreement could total up to an additional $200,000. We are
also required to pay royalties on future net sales of products associated with these patent rights.
In March 2007, we entered into an exclusive license agreement for the development and
commercialization of products covered by certain patent rights owned by Intracel Holdings, Inc., a
privately held corporation. We paid Intracel $150,000 in March 2007 as an up-front license fee
that provides 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 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, 2006 and in our notes to the financial statements set forth in Item 1 of this
Quarterly Report on Form 10-Q, we believe the following accounting policies are most critical to
aid in fully understanding and evaluating our reported financial results.
Available-for-Sale Securities
We designate our marketable securities as available-for-sale securities. Available-for-sale
securities are carried at fair value with the unrealized gains and losses, net of tax, if any,
reported as accumulated other comprehensive income (loss) in stockholders equity. Realized gains
and losses and declines in value judged to be other-than-temporary on available-for-sale securities
are included in investment income. Interest and dividends on securities classified as
available-for-sale are included in investment income.
Accrued Research and Development
We charge all research and development expenses, both internal and external costs, to
operations as incurred. External costs consist of fees paid to consultants and other outside
providers under service contracts. Costs incurred under fixed fee contracts are accrued ratably
over the contract period absent any knowledge that the services will be performed other than
ratably. Costs incurred under contracts to perform clinical trials are accrued on a
patients-treated basis consistent with the typical terms of reimbursement. Upon termination of such
contracts, we are normally only liable for costs incurred to date. As a result, accrued research
and development expenses represent our estimated contractual liability to outside service providers
at any of the relevant times.
Impairment of Long-Lived Assets
On August 2, 1999, we entered into an exclusive license for the commercial development, use
and sale of products or services covered by certain patent rights owned by Arizona State
University. The present value of the amount payable under the license agreement has been
capitalized based on a discounted cash flow model and is being amortized over the term of the
agreement (approximately 15.5 years).
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We review this asset for impairment whenever there are
indications of impairment based on an undiscounted net cash flow approach, in accordance with
Statement of Financial Accounting Standards No. 144, Accounting for the Impairment or Disposal of
Long-lived Assets (SFAS 144). If the undiscounted cash flows of an intangible asset are less than
the carrying value of an intangible asset, the intangible asset is written down to the discounted
cash flow value.
Stock-Based Compensation
Effective January 1, 2006, we adopted SFAS 123R, Share-Based Payment, which requires
the expense recognition of the estimated fair value of all share-based payments issued to
employees. Prior to the adoption of SFAS 123R, the estimated fair value associated with such
awards was not recorded as an expense, but rather was disclosed in a footnote to our financial
statements. For the nine -month period ended September 30, 2007, we recorded approximately
$924,000 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, | ||
| 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 September 30, 2007, we granted options to
purchase 200,000 shares of our common stock valued using these assumptions. The majority of the
stock option expense recorded in the three-month period ended September 30, 2007 relates to
continued vesting of stock options and restricted stock that were granted prior to January 1, 2006.
In accordance with the transition provisions of SFAS 123R, the grant date estimates of fair value
associated with prior awards, which were also calculated using the Black-Scholes option pricing
model, have not been changed. The specific valuation assumptions that were utilized for purposes
of deriving an estimate of fair value at the time that prior awards were issued are as disclosed in
our prior Annual Reports on Form 10-K, as filed with the SEC.
Upon adoption of SFAS 123R, we were also required to estimate the level of award forfeitures
expected to occur and record compensation expense only for those awards that are ultimately
expected to vest. This requirement applies to all awards that are not yet vested, including awards
granted prior to January 1, 2006. Accordingly, we performed a historical analysis of option awards
that were forfeited prior to vesting, and ultimately recorded total stock option expense that
reflected this estimated forfeiture rate. In our calculation, we segregated participants into two
distinct groups, (1) directors and officers and (2) employees, and our estimated forfeiture rates
were calculated at 0% and 50%, respectively. This analysis will be re-evaluated quarterly and the
forfeiture rate will be adjusted as necessary. Ultimately, the actual expense recognized over the
vesting period will only be for those shares that vest.
Tax Matters
As of December 31, 2006, we had net operating loss carry-forwards of approximately
$111,500,000 for U.S. income tax purposes, which expire through 2026. Due to the degree of
uncertainty related to the ultimate use of these loss carry-forwards, we have fully reserved this
future benefit. Additionally, the future utilization of the U.S. net operating loss carry-forwards
is subject to limitations under the change in stock ownership rules of the Internal Revenue
Service.
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Item 3. Quantitative and Qualitative Disclosures About Market Risk
At September 30, 2007, we did not hold any derivative financial instruments, commodity-based
instruments or other long-term debt obligations. We have adopted an Investment Policy and maintain
our investment portfolio in accordance with the Investment Policy. The primary objectives of the
Investment Policy 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
their relatively short duration, we believe 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 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, that
have materially affected, or are reasonably likely to materially affect, our internal control over
financial reporting.
Important Considerations.
The effectiveness of our disclosure controls and procedures and our internal control over
financial reporting is subject to various inherent limitations, including cost limitations,
judgments used in decision making, assumptions about the likelihood of future events, the soundness
of our systems, the possibility of human error, and the risk of fraud. Moreover, projections of any
evaluation of effectiveness to future periods are subject to the risk that controls may become
inadequate because of changes in conditions and the risk that the degree of compliance with
policies or procedures may deteriorate over time. Because of these limitations, there can be no
assurance that any system of disclosure controls and procedures or internal control over financial
reporting will be successful in preventing all errors or fraud or in making all material
information known in a timely manner to the appropriate levels of management.
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Table of Contents
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, 2006 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
None.
Item 6. Exhibits
10.1
|
Amendment No. 2 to Employment Agreement between the Company and Joel-Tomas Citron, dated July 9, 2007 (incorporated by reference from the Companys Current Report on Form 8-K filed on July 11, 2007) | |
10.2
|
Employment Agreement between the Company and Patricia Walicke dated July 27, 2007 (incorporated by reference from the Companys Current Report on Form 8-K filed on August 1, 2007 | |
10.3
|
Separation Agreement between the Company and Peter Harris, M.D. dated August 31,2007 | |
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:
November 7, 2007
|
By: | /s/ Richard Chin | ||||
Richard Chin, M.D. President and Chief Executive Officer |
||||||
Date:
November 7, 2007
|
By: | /s/ James B. Murphy | ||||
Vice President and Chief Financial Officer and Chief Accounting Officer |
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EXHIBIT INDEX
Exhibit | ||
Number | Description | |
10.1
|
Amendment No. 2 to Employment Agreement between the Company and Joel-Tomas Citron, dated July 9, 2007 (incorporated by reference from the Companys Current Report on Form 8-K filed on July 11, 2007) | |
10.2
|
Employment Agreement between the Company and Patricia Walicke dated July 27, 2007 (incorporated by reference from the Companys Current Report on Form 8-K filed on August 1, 2007 | |
10.3
|
Separation Agreement between the Company and Peter Harris, M.D. dated August 31,2007 | |
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. |
23