Oncotelic Therapeutics, Inc. - Quarter Report: 2008 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, 2008
OR
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number: 0-21990
OXiGENE, INC.
(Exact name of registrant as specified in its charter)
Delaware | 13-3679168 | |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
230 THIRD AVENUE
WALTHAM, MA 02451
(Address of principal executive offices, including zip code)
WALTHAM, MA 02451
(Address of principal executive offices, including zip code)
(781) 547-5900
(Registrants telephone number, including area code)
(Registrants telephone number, including area code)
Not applicable
(Former name, former address and former fiscal year, if changed since last report)
(Former name, former address and former fiscal year, if changed since last report)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
a non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated filer, accelerated filer and smaller reporting company in
Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o | Accelerated filer þ | Non-accelerated filer o | Smaller reporting company o | |||
(Do not check if a smaller reporting company) |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes o No þ
As of April 25, 2008, 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
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20 | ||||||||
21 | ||||||||
EX-31.1 Section 302 Certification of President and Chief Executive Officer | ||||||||
EX-31.2 Section 302 Certification of Vice President and Chief Financial Officer | ||||||||
EX-32.1 Section 906 Certification of PEO & PFO |
3
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PART IFINANCIAL INFORMATION
Item 1. Financial StatementsUnaudited
OXiGENE, Inc.
Condensed Balance Sheets
(All amounts in thousands, except per share data)
(Unaudited)
Condensed Balance Sheets
(All amounts in thousands, except per share data)
(Unaudited)
March 31, | December 31, | |||||||
2008 | 2007 | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 11,492 | $ | 8,527 | ||||
Available-for-sale securities |
11,621 | 19,911 | ||||||
Prepaid expenses |
553 | 354 | ||||||
Other current assets |
82 | 72 | ||||||
Total current assets |
23,748 | 28,864 | ||||||
Furniture and fixtures, equipment and leasehold improvements |
1,362 | 1,343 | ||||||
Accumulated depreciation |
(1,155 | ) | (1,122 | ) | ||||
207 | 221 | |||||||
License agreements, net of accumulated amortization of $847 and $822 at
March 31, 2008 and December 31, 2007, respectively |
654 | 679 | ||||||
Other assets |
171 | 300 | ||||||
Total assets |
$ | 24,780 | $ | 30,064 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 1,273 | $ | 1,370 | ||||
Accrued research and development |
2,995 | 2,713 | ||||||
Accrued other |
711 | 901 | ||||||
Total current liabilities |
4,979 | 4,984 | ||||||
Rent loss accrual |
88 | 223 | ||||||
Total liabilities |
5,067 | 5,207 | ||||||
Commitments and contingencies |
||||||||
Stockholders equity: |
||||||||
Common stock, $.01 par value, 100,000 shares authorized; 28,542
shares at March 31, 2008 and 28,505 shares at December 31, 2007,
issued and outstanding |
285 | 285 | ||||||
Additional paid-in capital |
162,662 | 162,358 | ||||||
Accumulated deficit |
(143,246 | ) | (137,801 | ) | ||||
Accumulated other comprehensive income |
12 | 15 | ||||||
Total stockholders equity |
19,713 | 24,857 | ||||||
Total liabilities and stockholders equity |
$ | 24,780 | $ | 30,064 | ||||
See accompanying notes.
4
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OXiGENE, Inc.
Condensed Statements of Operations
(All amounts in thousands, except per share data)
(Unaudited)
Condensed Statements of Operations
(All amounts in thousands, except per share data)
(Unaudited)
Three months ended | ||||||||
March 31, | ||||||||
2008 | 2007 | |||||||
Operating costs and expenses: |
||||||||
Research and development |
3,689 | 2,389 | ||||||
General and administrative |
2,048 | 2,124 | ||||||
Total operating costs and expenses |
5,737 | 4,513 | ||||||
Loss from operations |
(5,737 | ) | (4,513 | ) | ||||
Investment income |
287 | 572 | ||||||
Other income (expense), net |
5 | (7 | ) | |||||
Net loss |
$ | (5,445 | ) | $ | (3,948 | ) | ||
Basic and diluted net loss per common share |
$ | (0.19 | ) | $ | (0.14 | ) | ||
Weighted-average number of common shares outstanding |
28,070 | 27,875 |
See accompanying notes.
5
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OXiGENE, Inc.
Condensed Statements of Cash Flows
(All amounts in thousands)
(Unaudited)
Condensed Statements of Cash Flows
(All amounts in thousands)
(Unaudited)
Three months ended | ||||||||
March 31, | ||||||||
2008 | 2007 | |||||||
Operating activities: |
||||||||
Net loss |
$ | (5,445 | ) | $ | (3,948 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Depreciation
and amortization |
58 | 52 | ||||||
Rent loss accrual |
(135 | ) | (27 | ) | ||||
Stock-based compensation |
442 | 543 | ||||||
Changes in operating assets and liabilities: |
||||||||
Prepaid expenses and other current assets |
(209 | ) | 59 | |||||
Accounts payable, accrued expenses and other payables |
(5 | ) | (288 | ) | ||||
Net cash used in operating activities |
(5,294 | ) | (3,609 | ) | ||||
Investing activities: |
||||||||
Purchase of available-for-sale securities |
(4,016 | ) | (4,515 | ) | ||||
Proceeds from sale of available-for-sale securities |
12,303 | 14,325 | ||||||
Purchase of furniture, fixtures and equipment |
(19 | ) | (7 | ) | ||||
Other assets |
129 | (5 | ) | |||||
Net cash provided by investing activities |
8,397 | 9,798 | ||||||
Financing activities: |
||||||||
Stock acquisition costs |
(138 | ) | | |||||
Net cash used in financing activities |
(138 | ) | | |||||
Increase in cash and cash equivalents |
2,965 | 6,189 | ||||||
Cash and cash equivalents at beginning of period |
8,527 | 15,687 | ||||||
Cash and cash equivalents at end of period |
$ | 11,492 | $ | 21,876 | ||||
See accompanying notes.
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OXiGENE, Inc.
Notes to Condensed Financial Statements
March 31, 2008
(Unaudited)
Notes to Condensed Financial Statements
March 31, 2008
(Unaudited)
1. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed financial statements have been prepared in accordance
with U.S. generally accepted accounting principles for interim financial information and with the
instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of
the information and footnotes required by U.S. generally accepted accounting principles for
complete financial statements. In the opinion of management, all adjustments (consisting primarily
of normal recurring accruals) considered necessary for a fair presentation have been included.
Operating results for the three months ended March 31, 2008 are not necessarily indicative of the
results that may be expected for the year ending December 31, 2008.
The balance sheet at December 31, 2007 has been derived from the audited 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, 2007, 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
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)
March 31, 2008 | December 31, 2007 | |||||||
Corporate bonds maturing in less than two years |
$ | 5,335 | $ | 5,819 | ||||
Commercial paper maturing in less than one year |
3,282 | 10,703 | ||||||
Certificate of deposit maturing in less than one year |
1,000 | | ||||||
Asset backed securities maturing in less than one year |
2,004 | 3,389 | ||||||
Total available-for-sale securities |
$ | 11,621 | $ | 19,911 | ||||
As of March 31, 2008, the Companys available-for-sale securities are at a net unrealized gain
position totaling approximately $12,000. As of March 31, 2008, four of the Companys available-for-sale securities were in an unrealized loss position, primarily attributable to the
fluctuation in short-term interest rates over the course of the three months ended March 31, 2008.
These securities are corporate bonds. Based on the recent difficulties in the credit markets, the
Company performed a further review of its securities and concluded that the fair values are
appropriate and no adjustment was required. The Company determined that these unrealized losses
were temporary, after taking into consideration the time of ownership and the length of time such
securities have been in a loss position as well as the length of time they were in a unrealized
gain position.
Fair Value
In September 2006, the Financial Accounting Standards Board (FASB) issued Statement of Financial
Accounting Standards (SFAS) No. 157, Fair Value Measurements, effective for financial statements
issued for fiscal years beginning after November 15, 2007. SFAS No. 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 until the first quarter of 2009
the effective date of SFAS No. 157 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 No. 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 | defined as quoted prices in active markets; |
|
Level 2 inputs | which 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 | which are valuations based on unobservable inputs. |
The following table summarizes our assets that were measured at fair value as of March 31,
2008 (in thousands):
Fair Value Measurement at Reporting Date Using: | ||||||||||||||||
Significant Other | Significant | |||||||||||||||
Quoted Prices in | Observable | Unobservable | ||||||||||||||
Active Markets | Inputs | Inputs | Fair Value | |||||||||||||
(Level 1) | (Level 2) | (Level 3) | March 31, 2008 | |||||||||||||
Cash Equivalents |
||||||||||||||||
Money Market Fund |
$ | 8,038 | $ | | $ | | $ | 8,038 | ||||||||
Corporate Bonds |
| 2,768 | | 2,768 | ||||||||||||
Total Cash Equivalents |
8,038 | 2,768 | | 10,806 | ||||||||||||
Corporate Bonds |
| 5,335 | | 5,335 | ||||||||||||
Commercial paper |
| 3,282 | | 3,282 | ||||||||||||
Certificates of deposit |
| 1,000 | | 1,000 | ||||||||||||
Asset-backed securities |
| 2,004 | | 2,004 | ||||||||||||
Total Available for Sale |
| 11,621 | | 11,621 | ||||||||||||
Total |
$ | 8,038 | $ | 14,389 | $ | | $ | 22,427 | ||||||||
Cash of
$0.7 million is not included in our SFAS 157 level hierarchy
disclosure.
Accrued Research and Development
The Company charges all research and development expenses, both internal and external costs,
to operations as incurred. The Companys research and development costs represent expenses incurred
from the engagement of outside professional service organizations, product manufacturers and
consultants associated with the development of the Companys potential product candidates. The
Company recognizes expense associated with these arrangements based on the completion of activities
as specified in the applicable contracts. Costs incurred under fixed fee contracts are accrued
ratably over the contract period absent any knowledge that the services will be performed other
than ratably. Costs incurred under contracts with clinical trial sites and principal investigators
are generally accrued on a patient-treated basis consistent with the terms outlined in the
contract. In determining costs incurred on some of these programs, the Company takes into
consideration a number of factors, including estimates and input provided by internal program
managers. Upon termination of such contracts, the Company is normally only liable for costs
incurred and committed to date. As a result, accrued research and development expenses represent
the Companys estimated contractual liability to outside service providers at any relevant time.
Net Loss Per Share
Basic and diluted net loss per share 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 3,028,000 and 2,489,000 at March 31, 2008 and 2007, respectively, were excluded from
the calculation of weighted average shares for diluted loss per share.
Stock-based Compensation
The Company follows the provisions of Statement of Financial Accounting Standards No. 123R,
Share-Based Payment (SFAS 123R), which requires the expense recognition of the estimated fair
value of all share-based payments issued to employees. For the 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.
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During the three months ended
March 31, 2008 and 2007, options to purchase 24,000 and 161,000 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 $1.90 and $4.19 per share, respectively, for
the three months ended March 31, 2008 and 2007.
The Company granted options to purchase 100,000 shares of its common stock on April 30, 2007
to its Chief Business Officer at a grant price of $4.69. They were valued using 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 Business 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, 2008 and 2007:
Three months ended | Three months ended | |||||||
Weighted Average Assumptions | March 31, 2008 | March 31, 2007 | ||||||
Risk-free interest rate |
2.75 | % | 4.75 | % | ||||
Expected life |
5 years | 5 years | ||||||
Expected volatility |
74 | % | 89 | % | ||||
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, 2008:
Weighted Average | ||||||||||||||||
Weighted Average | Remaining | Aggregate | ||||||||||||||
Shares | Exercise Price | Contractual Life | Intrinsic Value | |||||||||||||
(In thousands) | (Years) | (In thousands) | ||||||||||||||
Options outstanding at December 31, 2007 |
2,148 | $ | 5.61 | 7.07 | $ | 44 | ||||||||||
Granted |
24 | 1.90 | | | ||||||||||||
Exercised |
| | | | ||||||||||||
Forfeited |
(11 | ) | 4.68 | | | |||||||||||
Options outstanding at March 31, 2008 |
2,161 | $ | 5.57 | 6.89 | $ | | ||||||||||
Option exercisable at March 31, 2008 |
1,247 | $ | 6.70 | |||||||||||||
Options vested or expected to vest at March 31, 2008 |
1,985 | $ | 5.73 | 6.69 | $ | | ||||||||||
As of March 31, 2008, there was approximately $1,871,000 of unrecognized compensation cost
related to stock option awards that is expected to be recognized as expense over a weighted average
period of 1.6 years. The total fair value of stock options that vested during the three months
ended March 31, 2008 and 2007 was approximately $76,000 and $12,000, respectively.
Non-Vested Stock
The following table summarizes the activity for unvested stock in connection with restricted stock grants during the three months ended March 31, 2008:
Shares | Weighted-Average | |||||||
(in thousands) | Fair Value | |||||||
Unvested at December 31, 2007 |
468 | $ | 4.73 | |||||
Granted |
| |||||||
Vested |
| |||||||
Forfeited |
| | ||||||
Unvested at March 31, 2008 |
468 | $ | 4.73 |
The Company recorded expense of approximately $196,000 and $275,000 related to outstanding
restricted stock awards during the three months ended March 31, 2008 and 2007, respectively. As of
March 31, 2008, there was approximately $1,489,000 of unrecognized compensation expense related to
restricted stock awards that will be recognized as expense over a weighted average period of 1.8
years.
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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 is being 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 March 31, 2008, 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 March 31, 2008.
In February 2008, the Company issued five year warrants exercisable beginning six months after
February 19, 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. As of March 31, 2008, there were no warrants
exercisable.
Comprehensive Income (Loss)
The Companys only item of other comprehensive income (loss) relates to unrealized gains and
losses on available for sale securities and is presented separately on the balance sheet, as
required.
A reconciliation of comprehensive loss is as follows:
Three months ended | ||||||||
March 31, | ||||||||
(In thousands) | ||||||||
2008 | 2007 | |||||||
Net loss as reported |
$ | (5,445 | ) | $ | (3,948 | ) | ||
Unrealized gains |
3 | 11 | ||||||
Comprehensive loss |
$ | (5,442 | ) | $ | (3,937 | ) | ||
2. License agreements
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. 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. 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 Stock Purchase Agreement
whichever is less, subject to certain conditions. The purchase price of these shares will be at a
discount of between 5 and 12 % from the volume weighted average price of the
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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 in the trading day immediately
preceding the commencement of the draw down, whichever is higher. In connection with the CEFF, the
Company issued a warrant to Kingsbridge to purchase 250,000 shares of its common stock at a price
of $2.74 per share exercisable beginning six months after February 19, 2008 for a period of five
years thereafter. The fair value of the warrant was determined on the date of issuance using the
Black-Scholes option valuation model applying the following assumptions: (i) a risk-free interest
rate of 2.75% ( ii) an expected term of 5.5 years, which represents the contractual term (iii) no
dividend yield and (iv) volatility of 83%. The estimated fair value of this warrant was $349,000,
which was recorded as contra-equity within additional paid in capital.
In
connection with the CEFF, the Company entered into Registration
Rights Agreement (RRA) with Kingsbridge. The RRA is effective through
the term of the CEFF and for two years thereafter. Pursuant to the
RRA, the Company is required to file a registration statement with
respect to the resale of the shares of common stock issuable under
the CEFF and the warrant within 60 days after entering into the CEFF
and to use commercially reasonable efforts to have such registration
statement declared effective by the SEC within 180 days of
entering into the CEFF. The RRA requires the Company to maintain
effectiveness of the registration statement throughout the term of
the RRA. If the Company (1) fails to maintain effectiveness of
the registration statement, or (2) has a deferral or suspension
of registration due to a black-out period, the Company may be subject
to liquidated damages. The liquidated damages are equal to the loss
that Kingsbridge would incur by holding shares of the Companys
common stock and being unable to sell those shares because of an
ineffective registration statement or black-out period. There is no
limit to the amount of the liquidated damages. As of March 31, 2008, the Company has not
accrued for any liquidated damages.
4. Recent Accounting Pronouncements
In December 2007, the Financial Accounting Standards Board (FASB) issued Statement of
Financial Accounting Standards (SFAS)No. 141 (revised 2007) (SFAS 141R), entitled Business
Combinations. SFAS 141R will change how business acquisitions are accounted for and will impact
financial statements both on the acquisition date and in subsequent periods. SFAS 141R will be
effective prospectively for business combinations for which the acquisition date is on or after the
beginning of the first annual reporting period beginning on or after December 15, 2008. The Company
does not expect the adoption of SFAS 141R to have a material effect on its financial position or
results of operations.
In December 2007,
the Emerging Issues Task Force (EITF) issued EITF 07-1 entitled
Accounting for Collaborative Arrangements. EITF 07-1 defines collaboration arrangements and
establishes reporting requirements for transactions between participants in a collaborative
arrangement and between participants in the arrangement and third parties. EITF 07-1 will be
effective for fiscal years beginning after December 15, 2008. The Company does not expect the
adoption of EITF 07-1 to have a material effect on its financial position or results of operations.
In June 2007, (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 on 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 adopted EITF 07-3 for
new contracts entered into after January 1, 2008 and the impact was immaterial.
In February 2007 (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 adopted SFAS 159 as of January 1, 2008 and the impact to the financial statements
was immaterial.
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, 2008 and March 31, 2007 should be read in conjunction with the sections of our
audited consolidated financial statements and notes thereto, as well as our
Managements Discussion and Analysis of Financial Condition and Results of Operations that
is included in our Annual Report on Form 10-K for the year ended December 31, 2007, and also with
the unaudited financial statements set forth in Part I, Item 1 of this Quarterly Report.
Overview
We are a clinical-stage, biopharmaceutical company developing novel therapeutics to treat
cancer and eye diseases. Our
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primary focus is the development and commercialization of product
candidates referred to as vascular disrupting agents (VDAs) that selectively disrupt abnormal blood
vessels associated with solid tumor progression and visual impairment, which are characterized by
abnormal blood vessel growth. Because our VDA product candidates act via a well-validated
therapeutic mechanism, inhibition of blood flow to tumors and neovascular lesions within the eye,
we believe that the risk associated with our product development programs may be lower than that of
many other agents that act via unvalidated therapeutic mechanisms.
Our most advanced therapeutic product candidate, ZYBRESTAT, is currently being evaluated in a
Phase II/III pivotal registration study as a potential treatment for anaplastic thyroid cancer
(ATC), a highly aggressive and lethal malignancy for which there are currently no approved
therapeutics and extremely limited treatment options. In addition, ZYBRESTAT is being evaluated in
Phase Ib and II clinical trials, in combination with established cancer treatment modalities, as a
potential treatment for other solid tumors, including non-small cell lung cancer (NSCLC),
platinum-resistant ovarian cancer, and head-and-neck cancer. Based upon preclinical results first
published by our collaborators in the November 2007 online issue of the journal Blood, we believe
that ZYBRESTAT and our other VDA product candidates may also have utility in the treatment of
hematological malignancies or liquid tumors.
In addition to developing ZYBRESTAT as an intravenously administered therapy for cancer
indications, we are developing a topical formulation of ZYBRESTAT for ophthalmological diseases and
conditions, such as age-related macular degeneration that are characterized by abnormal blood
vessel growth within the eye that results in loss of vision. We believe that a safe,
effective,convenient and topically-administered anti-vascular therapeutic would have advantages
over currently-approved anti-vascular, ophthalmological therapeutics, which must be injected
directly into patients eyes on a frequent basis. We currently anticipate initiating in 2008 human
clinical trials with a topical formulation of ZYBRESTAT in an ophthalmological indication.
We are currently evaluating a second-generation VDA product candidate, OXi4503, in a Phase I
clinical trial in patients with advanced solid tumors. We refer to OXi4503 as an ortho-quinone
prodrug (OQP). In preclinical studies, OXi4503 has shown potent anti-tumor activity, both as a
single-agent, and in combination with other cancer treatment modalities. We believe that OXi4503
is differentiated from other VDAs by its ability to exert (i) potent vascular disrupting effects on
tumor vasculature; and (ii) direct cytotoxic effects on tumor cells in a tumor-preferential
fashion.
Finally, under a sponsored research agreement with Baylor University, we are pursuing
discovery and development of novel, small-molecule therapeutics for the treatment of cancer that we
believe will be complementary with our later-stage VDA product candidates.
We are committed to a disciplined financial strategy and as such maintain a limited employee
and facilities base, with development, scientific, finance and administrative functions, which
include, among other things, product development, regulatory oversight and clinical testing,
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 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 $143,246,000 for the period from our
inception through March 31, 2008. We expect to incur significant additional operating losses over
at least the next several years, principally as a result of our continuing clinical trials and
anticipated research and development expenditures. The principal source of our working capital has
been the proceeds of private and public equity financings and the exercise of warrants and stock
options. We currently have no material amount of licensing or other fee income. As of March 31,
2008, we had no long-term debt or loans payable
Results of Operations
Revenue
Three Months Ended March 31, 2008 and 2007
We reported no licensing revenue for the three months ended March 31, 2008 and 2007,
respectively. 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.
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Costs and expenses
Three Months Ended March 31, 2008 and 2007
Costs and Expenses
The following table summarizes our operating expenses for the periods indicated, in thousands
and as a percentage of total expenses. This table also provides the changes in our operating
components and their percentages:
Three Months ended March 31, | ||||||||||||||||||||||||
2008 | 2007 | Increase (Decrease) | ||||||||||||||||||||||
% of Total | % of Total | |||||||||||||||||||||||
Operating | Operating | |||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | Amount | % | |||||||||||||||||||
Research and development |
$ | 3,689 | 64 | % | $ | 2,389 | 53 | % | $ | 1,300 | 54 | % | ||||||||||||
General and administrative |
2,048 | 36 | % | 2,124 | 47 | % | (76 | ) | (4 | )% | ||||||||||||||
Total operating expenses |
$ | 5,737 | 100 | % | $ | 4,513 | 100 | % | $ | 1,224 | 27 | % | ||||||||||||
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, | ||||||||||||||||||||||||
2008 | 2007 | Increase (Decrease) | ||||||||||||||||||||||
% of Total | % of Total | |||||||||||||||||||||||
Operating | Operating | |||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | Amount | % | |||||||||||||||||||
External services |
$ | 2,485 | 67 | % | $ | 1,502 | 63 | % | $ | 983 | 65 | % | ||||||||||||
Employee compensation and related |
1,061 | 29 | % | 719 | 30 | % | 342 | 48 | % | |||||||||||||||
Stock-based compensation |
79 | 2 | % | 75 | 3 | % | 4 | 5 | % | |||||||||||||||
Other |
64 | 2 | % | 93 | 4 | % | (29 | ) | (31 | )% | ||||||||||||||
Total research and development |
$ | 3,689 | 100 | % | $ | 2,389 | 100 | % | $ | 1,300 | 54 | % | ||||||||||||
The most significant increase
in research and development expenses of $1,300,000 from the three
months ended March 31, 2008 to the comparable period in 2007 is due to increased
expense for early-stage development activities of $983,000 (76%) conducted with outside contractors in support
of our ongoing clinical trial initiatives, the most significant of
which is the
ZYBRESTAT ATC Phase II/III pivotal registration study initiated in the second quarter of 2007. In
addition to the increase in external service costs was an increase of $342,000 in employee
compensation and related expenses due to additional contract and temporary services used to
support 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. The table also provides the changes in these components and
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their percentages:
Three Months ended March 31, | ||||||||||||||||||||||||
2008 | 2007 | Increase (Decrease) | ||||||||||||||||||||||
% of Total | % of Total | |||||||||||||||||||||||
Operating | Operating | |||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | Amount | % | |||||||||||||||||||
Employee compensation and related |
$ | 756 | 37 | % | $ | 687 | 32 | % | $ | 69 | 10 | % | ||||||||||||
Stock-based compensation |
276 | 13 | % | 468 | 22 | % | (192 | ) | (41 | )% | ||||||||||||||
Consulting and professional services |
773 | 37 | % | 504 | 24 | % | 269 | 53 | % | |||||||||||||||
Facilities related |
66 | 3 | % | 199 | 9 | % | (133 | ) | (67 | )% | ||||||||||||||
Other |
177 | 9 | % | 266 | 13 | % | (89 | ) | (33 | )% | ||||||||||||||
Total general and administrative |
$ | 2,048 | 100 | % | $ | 2,124 | 100 | % | $ | (76 | ) | (4 | )% | |||||||||||
The decrease of $192,000 in stock-based compensation in the first quarter of 2008 from the
first quarter of 2007 is related to an increase in the forfeiture rate used to calculate
compensation expense. There was also an increase in consulting and professional services
of $269,000 due to costs associated with ongoing efforts to raise
capital to support our programs. In addition, the increase in
consulting and professional services were related to costs to support
and protect our patents. That increase was partially offset by a reduction in rent expense of $145,000 due to a
reduction of our rent loss accrual. The reduction was caused by an extension of the sublease in
our Watertown facility at a higher base rent than previously anticipated for an additional 24
months starting in September 2008.
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 March 31, 2008, we had an accumulated deficit of
approximately $143,246,000. We expect to continue to incur expenses, resulting in operating losses,
over the next several years due to, among other factors, our continuing clinical trials, planned
future clinical trials, and other anticipated research and development activities. Our cash, cash
equivalents and available-for-sale securities balance was approximately $23,113,000 at March 31,
2008, compared to approximately $28,438,000 at December 31, 2007.
The following table summarizes our cash flow activities for the period indicated, in
thousands:
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Three Months | ||||
Ended March 31, | ||||
2008 | ||||
Operating activities: |
||||
Net loss |
$ | (5,445 | ) | |
Non-cash adjustments to net loss |
365 | |||
Changes in operating assets and liabilities |
(214 | ) | ||
Net cash used in operating activities |
(5,294 | ) | ||
Investing activities: |
||||
Net decrease in available-for-sale securities |
8,287 | |||
Purchase of furniture, fixtures and equipment |
(19 | ) | ||
Other |
129 | |||
Net cash provided by investing activities |
8,397 | |||
Financing activities: |
||||
Other |
(138 | ) | ||
Net cash used in financing activities |
(138 | ) | ||
Increase in cash and cash equivalents |
2,965 | |||
Cash and cash equivalents at beginning of period |
8,527 | |||
Cash and cash equivalents at end of period |
$ | 11,492 | ||
A major component of the non-cash adjustments to net loss in the three month period ended
March 31, 2008 is compensation expense of $442,000 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 our short term clinical trial needs and
the cash requirements to fund those needs.
In February 2008, we entered into the CEFF with Kingsbridge , pursuant to which Kingsbridge
committed to purchase, subject to certain conditions, up to 5,708,035 shares of our common stock
or up to an aggregate of $40,000,000 during the next three years. Under the CEFF, we are able to
draw down shares in tranches of up to a maximum of 3.5 % of our closing market value at the time of
the draw down or the alternative draw down amount calculated pursuant to the Common Stock Purchase
Agreement whichever is less, subject to certain conditions. The purchase price of these shares
will be at a discount of between 5 and 12 %t from the volume weighted average price of our common
stock for each of the eight trading days following the election to sell shares. Kingsbridge is not
obligated to purchase shares if the volume weighted average price of our stock is less than $1.25
per share or 85% of the closing share price of our stock in the trading day immediately preceding
the commencement of a draw down, whichever is higher. In connection with the CEFF, we issued a
warrant to Kingsbridge to purchase 250,000 shares of our common stock at a price of $2.74 per share
exercisable beginning six months after February 19, 2008 and for a period of five years thereafter.
We have filed a registration statement on Form S-1 to register the resale by Kingsbridge of the
shares issuable to Kingsbridge under the CEFF.
Our anticipated cash requirement for fiscal 2008 is expected to be between $22,000,000 and
$28,000,000. Our cash utilization amount is highly dependent on the progress of our potential
product development programs, particularly the rate of recruitment of patients in our human
clinical trials, much of which is not within our control as well as the timing of hiring
development staff to support our product development plans. We expect that our
current available cash will meet our cash requirements through the first quarter of fiscal 2009.
However, we expect to augment our cash, cash
equivalent and marketable securities balances as of March 31, 2008 of $23,113,000 with the
utilization of our newly implemented CEFF as well as through other forms of capital infusion. Our primary anticipated uses of funds during the 2008 fiscal year involve the
preclinical and clinical development of our product candidates under development. 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
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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.
In addition to equity capital financing, we continue to aggressively pursue other forms of
capital infusion including strategic alliances with organizations that have capabilities and/or
products that are complementary to our own, as well as program structured financing facilities in
order to continue the development of our potential product candidates.
If our existing funds are not sufficient to continue operations, we would be required to seek
additional funding and/or take other measures. There can be no assurance that additional financing
will be available on acceptable terms when needed, if at all.
In the event that all of the capital infusion initiatives discussed above are unsuccessful and
should we be unable to sell shares under the CEFF due to the limitations contained in the CEFF
agreement or our ability to register the securities with the SEC, by the end of our fiscal 2008 second quarter, we are prepared to implement cost reduction
measures. These cost reduction measures would include the cessation or delay of at least two of
the current or planned clinical trials of ZYBRESTAT and other supporting projects, the reduction
and delay in hiring of development and administrative staff, the cessation of our preclinical study
of our in-licensed antibody protein OXiMAb-24A, the delay or reduction in early stage
development efforts in research with respect to our second-generation VDA, OXi4503, and the
reduction of certain employee incentive programs.
The following table presents our contractual obligations and commercial commitments as of
March 31, 2008:
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 |
$ | 12,096 | $ | 10,236 | $ | 1,860 | $ | | $ | | ||||||||||
Operating leases |
1,326 | 719 | 607 | | | |||||||||||||||
Total contractual cash obligations |
$ | 13,422 | $ | 10,955 | $ | 2,467 | $ | | $ | | ||||||||||
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 $252,000 for the 12-month period ending March 31,
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, 2008, we have paid a total of $2,500,000 in connection with this
license. The agreement provides for additional payments in connection with the license arrangement
upon the initiation of certain clinical trials or the receipt of certain regulatory approvals,
which payments could be accelerated upon the achievement of certain financial milestones, as
defined in the agreement. We have made total milestone payments of $700,000 through March 31, 2008.
In the three months ended March 31, 2008, we did not make any payments pursuant to meeting a
financial milestone under the agreement. The license agreement also provides for additional
payments upon our election to develop certain additional compounds, as defined in the agreement.
Future milestone payments under this agreement could total up to an additional $200,000. We are
also required to pay royalties on future net sales of products associated with these patent rights.
In March 2007, we entered into an exclusive license agreement for the development and
commercialization of products covered by certain patent rights owned by Intracel Holdings, Inc., a
privately held corporation. We paid Intracel $150,000 in March 2007 as an up-front license fee
that provides 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
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periods. On an ongoing basis, we evaluate our estimates and judgments, including those related to intangible
assets. We base our estimates on historical experience and on various other factors that are
believed to be appropriate under the circumstances, the results of which form the basis for making
the judgments about the carrying value of assets and liabilities that are not readily apparent from
other sources. Actual results may differ from these estimates.
While our significant accounting policies are more fully described in Note 1 to our
consolidated financial statements included in our Annual Report on Form 10-K for the year ended
December 31, 2007 and in our notes to the financial statements set forth in Item 1 of this
Quarterly Report on Form 10-Q, we believe the following accounting policies are most critical to
aid in fully understanding and evaluating our reported financial results.
Available-for-Sale Securities
We designate our marketable securities as available-for-sale securities. Available-for-sale
securities are carried at fair value with the unrealized gains and losses, net of tax, if any,
reported as accumulated other comprehensive income (loss) in stockholders equity. Realized gains
and losses and declines in value judged to be other-than-temporary on available-for-sale securities
are included in investment income. Interest and dividends on securities classified as
available-for-sale are included in investment income.
Accrued Research and Development
We charge all research and development expenses, both internal and external costs, to
operations as incurred. External costs consist of fees paid to consultants and other outside
providers under service contracts. Costs incurred under fixed fee contracts are accrued ratably
over the contract period absent any knowledge that the services will be performed other than
ratably. Costs incurred under contracts to perform clinical trials are accrued on a
patients-treated basis consistent with the typical terms of reimbursement. Upon termination of such
contracts, we are normally only liable for costs incurred to date. As a result, accrued research
and development expenses represent our estimated contractual liability to outside service providers
at any of the relevant times.
Impairment of Long-Lived Assets
On August 2, 1999, we entered into an exclusive license for the commercial development, use
and sale of products or services covered by certain patent rights owned by Arizona State
University. The present value of the amount payable under the license agreement has been
capitalized based on a discounted cash flow model and is being amortized over the term of the
agreement (approximately 15.5 years). We review this asset for impairment whenever there are
indications of impairment based on an undiscounted net cash flow approach, in accordance with
Statement of Financial Accounting Standards No. 144, Accounting for the Impairment or Disposal of
Long-lived Assets (SFAS 144). If the undiscounted cash flows of an intangible asset are less than
the carrying value of an intangible asset, the intangible asset is written down to the discounted
cash flow value.
Stock-Based Compensation
Effective January 1, 2006, we adopted SFAS 123R, Share-Based Payment, which requires the
expense recognition of the estimated fair value of all share-based payments issued to employees.
Prior to the adoption of SFAS 123R, the estimated fair value associated with such awards was not
recorded as an expense, but rather was disclosed in a footnote to our financial statements. For
the three -month period ended March 31, 2008, we recorded approximately $355,000 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
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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, 2008, we granted options to
purchase 24,000 shares of our common stock valued using these assumptions. The majority of the
stock option expense recorded in the three-month period ended March 31, 2008 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 10% and 50%, respectively. This analysis will be re-evaluated quarterly and the
forfeiture rate will be adjusted as necessary. Ultimately, the actual expense recognized over the
vesting period will only be for those shares that vest.
Tax Matters
As of December 31, 2007, we had net operating loss carry-forwards of approximately
$130,685,000 for U.S. income tax purposes, which expire through 2027. Due to the degree of
uncertainty related to the ultimate use of these loss carry-forwards, we have fully reserved this
future benefit. Additionally, the future utilization of the U.S. net operating loss carry-forwards
is subject to limitations under the change in stock ownership rules of the Internal Revenue
Service.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
At March 31, 2008, we did not hold any derivative financial instruments, commodity-based
instruments or other long-term debt obligations. We have adopted an Investment Policy and 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
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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, 2007 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
4.1
|
Warrant for the purchase of shares of common stock, dated February 19, 2008, issued by the Registrant to Kingsbridge Capital Limited. Filed as Exhibit 4.1 to the Registrants Current Report on Form 8-K filed February 21, 2008 and incorporated herein by reference. | |
4.2
|
Registration Rights Agreement, dated February 19, 2008, by and between the Registrant and Kingsbridge Capital Limited Filed as Exhibit 4.2 to the Registrants Current Report on Form 8-K filed February 21, 2008 and incorporated herein by reference. | |
10.1
|
Common Stock Purchase Agreement, dated February 19, 2008, by and between the Registrant and Kingsbridge Capital Limited. Filed as Exhibit 10.1 to the Registrants Current Report on Form 8-K filed February 21, 2008 and incorporated herein by reference. | |
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 9, 2008 | By: | /s/ Richard Chin | ||
Richard Chin, M.D. | ||||
President and Chief Executive Officer | ||||
Date: May 9, 2008 | By: | /s/ James B. Murphy | ||
James B. Murphy | ||||
Vice President and Chief Financial Officer |
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EXHIBIT INDEX
Exhibit | ||
Number | Description | |
4.1
|
Warrant for the purchase of shares of common stock, dated February 19, 2008, issued by the Registrant to Kingsbridge Capital Limited. Filed as Exhibit 4.1 to the Registrants Current Report on Form 8-K filed February 21, 2008 and incorporated herein by reference. | |
4.2
|
Registration Rights Agreement, dated February 19, 2008, by and between the Registrant and Kingsbridge Capital Limited. Filed as Exhibit 4.2 to the Registrants Current Report on Form 8-K filed February 21, 2008 and incorporated herein by reference. | |
10.1
|
Common Stock Purchase Agreement, dated February 19, 2008, by and between the Registrant and Kingsbridge Capital Limited. Filed as Exhibit 10.1 to the Registrants Current Report on Form 8-K filed February 21, 2008 and incorporated herein by reference. | |
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. |
22