Oncotelic Therapeutics, Inc. - Quarter Report: 2011 March (Form 10-Q)
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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, 2011
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.) |
701 Gateway Blvd, Suite 210
South San Francisco, CA 94080
(Address of principal executive offices, including zip code)
South San Francisco, CA 94080
(Address of principal executive offices, including zip code)
(650) 635-7000
(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 has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12
months (or such shorter period that the registrant was required to submit and post such
files). Yes o No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large
accelerated filer, accelerated filer, and smaller reporting company in Rule 12b-2 of the
Exchange Act.
Large accelerated filer o | Accelerated filer o | Non-accelerated filer o
(Do not check if a smaller reporting company) |
Smaller reporting company þ |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act). Yes o No þ
As of May 11, 2011, there were 9,542,035 shares of the Registrants Common Stock issued and
outstanding.
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OXiGENE, INC.
Cautionary Factors that May Affect Future Results
Cautionary Factors that May Affect Future Results
The disclosure and analysis by OXiGENE, Inc. (the Company) in this report contain
forward-looking statements. Forward-looking statements give managements current
expectations or forecasts of future events. You can identify these statements by the fact that
they do not relate strictly to historic or current facts. They use words, such as
anticipate, estimate, expect, project, intend, plan, believe, and other words
and terms of similar meaning. These include statements, among others, relating to the
sufficiency of our financial resources, our planned future actions, our clinical trial plans,
our research and development plans and expected outcomes, our prospective products or product
approvals, our beliefs regarding our intellectual property position, 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 need for additional funds
to finance its operations in the near term; the Companys history of losses, anticipated
continuing losses and uncertainty of future financing; 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 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.
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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, 2011 | December 31, 2010 | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 2,630 | $ | 4,602 | ||||
Restricted cash |
75 | 75 | ||||||
Prepaid expenses |
553 | 256 | ||||||
Other current assets |
63 | 75 | ||||||
Total current assets |
3,321 | 5,008 | ||||||
Furniture and fixtures, equipment and leasehold improvements |
1,512 | 1,512 | ||||||
Accumulated depreciation |
(1,442 | ) | (1,425 | ) | ||||
70 | 87 | |||||||
License agreements, net of accumulated amortization
of $1,138 and $1,114 at March 31, 2011 and December 31,
2010, respectively |
362 | 386 | ||||||
Other assets |
98 | 86 | ||||||
Total assets |
$ | 3,851 | $ | 5,567 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT) |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 689 | $ | 458 | ||||
Accrued research and development |
1,509 | 2,125 | ||||||
Accrued other |
588 | 628 | ||||||
Total current liabilities |
2,786 | 3,211 | ||||||
Derivative liability long term |
17 | 7,611 | ||||||
Total liabilities |
2,803 | 10,822 | ||||||
Commitments and contingencies (Note 3) |
||||||||
Stockholders equity (deficit): |
||||||||
Preferred Stock, $.01 par value, 15,000 shares
authorized; 0 shares issued and outstanding at March 31,
2011 and December 31, 2010 |
| | ||||||
Common stock, $.01 par value, 300,000 shares
authorized and 7,739 shares issued and outstanding at March
31, 2011; 300,000 shares authorized and 5,501 shares issued
and outstanding at December 31, 2010 |
77 | 55 | ||||||
Additional paid-in capital |
209,534 | 202,390 | ||||||
Accumulated deficit |
(208,563 | ) | (207,700 | ) | ||||
Total stockholders equity (deficit) |
1,048 | (5,255 | ) | |||||
Total liabilities and stockholders equity (deficit) |
$ | 3,851 | $ | 5,567 | ||||
See accompanying notes.
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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, | ||||||||
2011 | 2010 | |||||||
Operating costs and expenses (1): |
||||||||
Research and development |
$ | 1,683 | $ | 4,185 | ||||
General and administrative |
1,385 | 1,703 | ||||||
Restructuring |
| 510 | ||||||
Total operating costs and expenses |
3,068 | 6,398 | ||||||
Loss from operations |
(3,068 | ) | (6,398 | ) | ||||
Change in fair value of warrants and other
financial instruments |
2,210 | (4,633 | ) | |||||
Investment income |
1 | 7 | ||||||
Other income (expense), net |
(6 | ) | (4 | ) | ||||
Net loss |
$ | (863 | ) | $ | (11,028 | ) | ||
Basic and diluted net loss per share |
$ | (0.13 | ) | $ | (3.42 | ) | ||
Weighted-average number of common shares
outstanding |
6,554 | 3,222 | ||||||
(1) | Includes share based compensation expense as follows: |
Research and development
|
$ | 48 | $ | 35 | ||||
General and administrative
|
109 | 157 | ||||||
Total share based compensation expense
|
$ | 157 | $ | 192 | ||||
See accompanying notes.
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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, | ||||||||
2011 | 2010 | |||||||
Operating activities: |
||||||||
Net loss |
$ | (863 | ) | $ | (11,028 | ) | ||
Adjustments to reconcile net loss to net cash used in operating
activities: |
||||||||
Change in fair value of warrants and other financial instruments |
(2,210 | ) | 4,633 | |||||
Depreciation |
17 | 28 | ||||||
Amortization of license agreement |
24 | 24 | ||||||
Stock-based compensation |
157 | 192 | ||||||
Changes in operating assets and liabilities: |
||||||||
Prepaid expenses and other current assets |
(285 | ) | (29 | ) | ||||
Accounts payable, accrued expenses and other payables |
(425 | ) | (413 | ) | ||||
Net cash used in operating activities |
(3,585 | ) | (6,593 | ) | ||||
Investing activities: |
||||||||
Change in other assets |
(12 | ) | 14 | |||||
Net cash provided (used) by investing activities |
(12 | ) | 14 | |||||
Financing activities: |
||||||||
Proceeds from issuance of common stock, net of acquisition costs |
1,625 | 6,655 | ||||||
Proceeds from exercise of employee stock plans |
| 6 | ||||||
Net cash provided by financing activities |
1,625 | 6,661 | ||||||
(Decrease) increase in cash and cash equivalents |
(1,972 | ) | 82 | |||||
Cash and cash equivalents at beginning of period |
4,602 | 13,932 | ||||||
Cash and cash equivalents at end of period |
$ | 2,630 | $ | 14,014 | ||||
Non-cash Disclosures: |
||||||||
Fair market value of stock issued in exchange for warrants |
$ | 5,381 | $ | | ||||
Fair market value reclassification of CEFF warrants to
equity in connection with warrant exchange |
$ | 3 | $ | | ||||
Fair market value of private placement warrants at issuance |
$ | | $ | 11,868 | ||||
Fair market value reclassification of CEFF warrants to
liabilities in connection with private placement |
$ | | $ | 103 |
See accompanying notes.
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OXiGENE, Inc.
Notes to Condensed Financial Statements
March 31, 2011
(Unaudited)
Notes to Condensed Financial Statements
March 31, 2011
(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. They have
been prepared on a basis which assumes that the Company will continue as a going concern,
which contemplates the realization of assets and the satisfaction of liabilities and
commitments in the normal course of business. The financial statements do not include all of
the information and footnotes required by U.S. generally accepted accounting principles for
complete financial statements. In the opinion of management, however, all adjustments
(consisting primarily of normal recurring accruals) considered necessary for a fair
presentation have been included. Operating results for the three months ended March 31, 2011
are not necessarily indicative of the results that may be expected for the year ending
December 31, 2011.
The balance sheet at December 31, 2010 has been derived from the audited financial
statements at that date but does not include all of the information and footnotes required by
generally accepted accounting principles for complete financial statements. For further
information, refer to the financial statements and footnotes thereto included in the Annual
Report on Form 10-K for OXiGENE, Inc. (the Company) for the year ended December 31, 2010,
which can be found at www.oxigene.com. The Report of Independent Registered Public
Accounting Firm at the beginning of the Consolidated Financial Statements section in our
Annual Report on Form 10-K for the year ended December 31, 2010 includes a going concern
explanatory paragraph.
In 2010, the Company entered into an at the market (ATM) equity offering sales
agreement with McNicoll, Lewis & Vlak LLC, or MLV, pursuant to which it may issue and sell
shares of its common stock from time to time through MLV acting as sales agent and
underwriter. Sales of the Companys common stock through MLV, if any, are made on the
Companys principal trading market by means of ordinary brokers transactions at market
prices, in block transactions or as otherwise agreed by MLV and the Company. MLV uses its
commercially reasonable efforts to sell the Companys common stock from time to time, based
upon instructions from the Company (including any price, time or size limits the Company may
impose). The Company pays MLV a commission rate of up to 7.0% of the gross sales price per
share of any common stock sold through MLV as agent under the sales agreement. The Company has
also provided MLV with customary indemnification rights.
During the three months ended March 31, 2011, the Company sold approximately 677,000
shares of common stock pursuant to the ATM sales agreement resulting in net proceeds to the
Company of approximately $1,625,000. From April 1, 2011 through May 2, 2011, the Company sold
approximately 1,799,000 shares of common stock pursuant to the ATM sales agreement resulting
in net proceeds to the Company of approximately $3,000,000. With the sale of shares under the
ATM in April and May 2011, the Company has sold the maximum amount allowed under its
prospectus supplement to Form S-3 dated January 31, 2011. No assurance can be given that the
Company will sell any additional shares under the ATM sales agreement, or, if it does, as to
the price or amount of shares that it will sell, or the dates on which any such sales will
take place.
Including the net proceeds from the sale of shares under the ATM sales agreement in April
and May 2011 described above, the Company expects that its financial resources will be
sufficient to fund its operations through August of 2011. OXiGENEs cash requirements may
vary materially from those now planned for or anticipated by management due to numerous risks
and uncertainties. The Company is aggressively pursuing other forms of capital infusion
including public or private financing, strategic partnerships or other arrangements with
organizations that have capabilities and/or products that are complementary to the Companys
own capabilities and/or products, in order to continue the development of its product
candidates. If the Company is unable to access additional funds when needed, it may not be
able to continue the development of its product candidates or the Company could be required to
delay, scale back or eliminate some or all of its development programs and other operations.
Any additional equity financing, which may not be available to the Company or may not be
available on favorable terms, may be dilutive to its current stockholders and debt financing,
if available, may involve restrictive covenants. If the Company accesses funds through
collaborative or licensing arrangements, it may be required to relinquish rights to some of
its technologies or product candidates that it would otherwise seek to develop or
commercialize on its own, on terms that are not favorable to the Company. The Companys
ability to access capital when needed is not assured and, if not achieved on a timely basis,
will materially harm its business, financial condition and results of operations. This
uncertainty creates doubt about the Companys ability to continue as a going concern.
Fair Value
The Company is 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. The fair value hierarchy prioritizes valuation inputs based on the observable nature
of those inputs. The fair value hierarchy applies only to the valuation inputs used in
determining the reported fair value of the Companys investments and is not a measure of the
investment credit quality. The hierarchy defines three levels of valuation inputs:
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Level 1 inputs | Quoted prices in active markets; | |
Level 2 inputs | Generally include inputs with other observable qualities, such as quoted prices in active markets for similar assets or quoted prices for identical assets in inactive markets; and | |
Level 3 inputs | Valuations based on unobservable inputs. |
As of March 31, 2011 and December 31, 2010, OXiGENE did not hold any assets or
liabilities subject to these standards, except the derivative liabilities and other financial
instruments discussed below in Warrants, which are valued using level 3 inputs. As of March
31, 2011 and December 31, 2010, OXiGENE held $2,705,000 and $4,677,000 in cash, cash
equivalents and restricted cash, respectively. The Company has adopted the fair value
standards as it relates to the non-recurring fair value measurements, such as the assessment
of other long-lived assets for impairment.
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 expenses associated with these arrangements based
on the completion of activities as specified in the applicable contracts. Costs incurred under
fixed-fee contracts are expensed ratably over the contract period absent any knowledge that
the services will be performed other than ratably. Costs incurred under contracts with
clinical trial sites and principal investigators are generally accrued on a patient-treated
basis consistent with the terms outlined in the contract. In determining costs incurred on
some of these programs, the Company takes into consideration a number of factors, including
estimates and input provided by internal program managers. Upon termination of such contracts,
the Company is normally only liable for costs incurred and committed to date. As a result,
accrued research and development expenses represent the Companys reasonably estimated
contractual liability to outside service providers at any particular point in time.
Accounting for Derivative Financial Instruments Indexed to and Potentially Settled in the Companys Common stock
The Company evaluates all derivative financial instruments issued in connection with
its equity offerings when determining the proper accounting treatment for such
instruments in the Companys financial statements. The Company considers a number of
generally accepted accounting principles to determine such treatment. The Company
performs a number of steps to evaluate the features of the instrument against the
guidance provided in the accounting pronouncements in order to determine the appropriate
accounting treatment. The Companys policy with regard to settling outstanding financial
instruments is to settle those with the earliest maturity date first which essentially
sets the order of preference for settling the awards. In the majority of circumstances,
the Company utilizes the Black Scholes method to determine the fair value of its
derivative financial instruments. In some cases, where appropriate, the Company utilizes
the Binomial method or other appropriate methods to determine the fair value of such
derivative financial instruments. Key valuation factors in determining the fair value
include, but are not limited to, the current stock price as of the date of measurement,
the exercise price, the remaining contractual life, expected volatility for the
instrument and the risk-free interest rate. Changes in fair value are recorded as a gain
or loss in the Companys Statement of Operations with the corresponding amount recorded
as an adjustment to liability on its Balance Sheet. The expected volatility factor, in
particular, is subject to significant variability from measurement period to measurement
period and can result in large gains or losses from period to period.
Patents and Patent Applications
The Company has filed applications for patents in connection with technologies that it is
developing. The patent applications and any patents issued as a result of these applications
are important to the protection of the Companys technologies that may result from its
research and development efforts. Costs associated with patent applications and maintaining
patents are expensed as general and administrative expense as incurred.
Stock-based Compensation
The Company expenses the estimated fair value of all share-based payments issued to
employees over the vesting period. The Company has a 2005 Stock Plan (2005 Plan), which
superseded its 1996 Stock Option Plan that provides for the award of
stock options, restricted stock and stock appreciation rights to employees, directors and
consultants to the Company. The Company also has a 2009 Employee Stock Purchase Plan (2009
ESPP).
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The Company is 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, OXiGENE performs a historical analysis of option awards that
were forfeited prior to vesting, and ultimately records total stock option expense that
reflects this estimated forfeiture rate. In the Companys calculation, it segregates
participants into two distinct groups, (1) directors and officers and (2) employees, and
OXiGENEs applies estimated forfeiture rates using the Straight Line method. This analysis is
re-evaluated quarterly and the forfeiture rate is adjusted as necessary.
Income Taxes
The Company accounts for income taxes based upon the provisions of ASC 740, Income Taxes.
Under ASC 740, deferred taxes are recognized using the liability method whereby tax rates are
applied to cumulative temporary differences between carrying amounts of assets and liabilities
for financial reporting purposes and the amounts used for income tax purposes based on when
and how they are expected to affect the tax return.
Realization of the deferred tax assets is uncertain due to the historical losses of the
Company and therefore a full valuation allowance has been established.
2. Furniture and Fixtures, Equipment and Leasehold Improvements
Furniture and fixtures, equipment and leasehold improvements are recorded at cost.
Depreciation is recorded using the straight-line method over the estimated useful lives of the
assets, which range from three to five years.
Property and equipment consisted of the following at the dates indicated below:
March 31, 2011 | December 31, 2010 | |||||||
(in thousands) | ||||||||
Leasehold improvements |
$ | 449 | $ | 449 | ||||
Equipment |
647 | 647 | ||||||
Furniture and fixtures |
416 | 416 | ||||||
Total gross assets |
1,512 | 1,512 | ||||||
Less accumulated depreciation |
(1,442 | ) | (1,425 | ) | ||||
Total property and equipment |
$ | 70 | $ | 87 | ||||
3. License agreements
In August 1999, the Company entered into an exclusive license agreement for the
commercial development, use and sale of products or services covered by certain patent rights
owned by Arizona State University. From the inception of the agreement through March 31, 2011,
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.
The Company expects to record amortization expense related to this license agreement of
approximately $8,100 per month through November 2014. The net book value at March 31, 2011 and
December 31, 2010, was approximately $362,000 and $386,000, respectively. The Company performs
an impairment analysis of its long-lived assets if triggering events occur. The Company
conducts reviews for such triggering events periodically and, even though triggering events
such as a going concern
opinion and continuing losses occurred, the Company has determined that there is no impairment
to this asset. The license agreement provides for additional payments from the Company upon
the initiation of certain clinical trials or the completion of certain regulatory approvals,
which payments could be accelerated upon the achievement of certain financial milestones as
defined in the agreement. To date, no clinical trials triggering payments under the agreement
have been completed and no regulatory approvals have been obtained. The Company expenses these
payments to research and development in the period the obligation becomes both probable and
estimable.
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4. Stockholders Equity (Deficit), Common and Preferred Shares
The Company had 300,000,000 shares of common stock authorized as of March 31, 2011 and
December 31, 2010, respectively. As of March 31, 2011 the Company had approximately 7,739,000
shares of common stock issued and outstanding.
In July 2010, the Company entered into an at the market (ATM) equity offering sales
agreement with McNicoll, Lewis & Vlak LLC, or MLV, pursuant to which it may issue and sell
shares of its common stock from time to time through MLV acting as its sales agent and
underwriter. Sales of the Companys common stock through MLV, if any, are made on the
Companys principal trading market by means of ordinary brokers transactions at market
prices, in block transactions or as otherwise agreed by MLV and the Company. MLV uses its
commercially reasonable efforts to sell the Companys common stock from time to time, based
upon instructions from the Company (including any price, time or size limits the Company may
impose). The Company pays MLV a commission rate of up to 7.0% of the gross sales price per
share of any common stock sold through MLV as agent under the sales agreement. The Company has
also provided MLV with customary indemnification rights. During the three months ended March
31, 2011, the Company sold approximately 677,000 shares of common stock pursuant to the ATM
sales agreement resulting in net proceeds to the Company of approximately $1,625,000. From
April 1, 2011 through May 2, 2011, the Company sold approximately 1,799,000 shares of common
stock pursuant to the ATM sales agreement resulting in net proceeds to the Company of
approximately $3,000,000. With the sale of shares under the ATM in April and May 2011, the
Company has sold the maximum amount allowed under its prospectus supplement to Form S-3 dated
January 31, 2011. No assurance can be given that the Company will sell any additional shares
under the ATM sales agreement, or, if it does, as to the price or amount of shares that it
will sell, or the dates on which any such sales will take place.
Reverse Stock Split
In February 2011, the Companys board of directors voted unanimously to implement a 1:20
reverse stock split of the Companys common stock, following authorization of the reverse
split by a shareholder vote on December 21, 2010. The reverse split became effective on
February 22, 2011. All of the share and per share values discussed and shown in the
consolidated financial statements prior to this date have been adjusted to reflect the effect
of this reverse stock split.
Warrant Exchange Agreements
On January 18, 2011, OXiGENE, entered into separate Warrant Exchange Agreements (Private
Placement Warrant Exchange) with each of the holders of Series A and Series C warrants to
purchase shares of common stock, issued in March 2010, pursuant to which, at the initial
closing, the warrant holders exchanged their outstanding Series A and Series C warrants having
ratchet price-based anti-dilution protections for (A) an aggregate of 1,096,933 shares of
common stock and (B) Series E Warrants to purchase an aggregate of 1,222,623 shares of common
stock. The Series E Warrants were not exercisable for six months, had an exercise price of
$4.60 per share (reflecting the market value of the shares of common stock as of the close of
trading on January 18, 2011, prior to the entry into the Warrant Exchange Agreements), and did
not contain any price-based anti-dilution protections. In addition, the Company agreed to
seek shareholder approval to issue, in exchange for the Series E Warrants, up to 457,544
additional shares of common stock to the warrant holders in a subsequent closing. The initial
closing occurred on January 20, 2011, and the subsequent closing took place on March 21, 2011,
following the stockholder meeting on March 18, 2011. As a result, there were no Series A,
Series C or Series E warrants outstanding as of March 31, 2011. Similar to the Series A and
Series C warrants, the Series E Warrants were classified as a liability during the period that
they were outstanding.
In connection with the warrant exchange, the Company also amended its Stockholder Rights
Agreement with American Stock Transfer & Trust Company, LLC, dated as of March 24, 2005, as
amended as of October 1, 2008, October 14, 2009 and March 10, 2010, to provide that the
provisions of the Stockholder Rights Agreement shall not apply to the transactions
contemplated by the Warrant Exchange Agreements.
The following table summarizes the number of shares of common stock of the Company issued
and the proceeds received during the three month period ended March 31, 2011:
Shares Issued in Connection with: | Shares Issued | Net Proceeds | ||||||
(in thousands) | ||||||||
Director fees |
8 | $ | | |||||
ATM |
677 | 1,625 | ||||||
Private Placement Warrant Exchange |
1,554 | | ||||||
Totals |
2,239 | $ | 1,625 | |||||
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Share issuances to our directors under the Director Compensation policy are described
below. The shares issued in connection with the Private Placement Warrant Exchange during the
three month period ended March 31, 2011 relate to the Warrant Exchange Agreements described
above.
Warrants, Options, Non-Vested Stock, 2009 ESPP and Director Compensation Policy
Warrants
The following is a summary of the Companys warrant-related Derivative liability activity for
the three months ended March 31, 2011 (in thousands):
Derivative liability outstanding at December 31, 2010 |
$ | 7,611 | ||
Impact of warrant exchange agreements |
(6,071 | ) | ||
CEFF warrants amounts reclassified to equity |
(3 | ) | ||
Net decrease in fair value of all warrants |
(1,520 | ) | ||
Derivative liability outstanding at March 31, 2011 |
$ | 17 | ||
The table below summarizes the value (in thousands) of the warrant-related derivative
liabilities recorded on the Companys balance sheet:
As of March 31, 2011 | As of December 31, 2010 | |||||||
Warrants Issued in Connection with: | Long-term | Long-term | ||||||
Committed Equity
Financing Facility |
$ | | $ | 6 | ||||
Direct Registration
Series I Warrants |
17 | 107 | ||||||
Private Placement Series
A Warrants |
| 4,143 | ||||||
Private Placement Series
C Warrants |
| 3,355 | ||||||
Total derivative liability |
$ | 17 | $ | 7,611 | ||||
The gain (loss) from the change in fair value of warrants and other financial instruments for the
three months ended March 31, 2011, and 2010 is summarized below (in thousands):
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Three months ended March 31, | ||||||||
2011 | 2010 | |||||||
Committed Equity Financing Facility Warrants |
$ | 3 | $ | 2 | ||||
Direct Registration Warrants |
90 | 225 | ||||||
Excess of value of the Private Placement
Warrants at issuance over the net proceeds
of the offering |
| (4,433 | ) | |||||
Gain recognized in connection with warrant
exchange agreements |
690 | | ||||||
Private Placement Warrants |
1,427 | (427 | ) | |||||
Total gain (loss) on change in fair market
value of derivatives |
$ | 2,210 | $ | (4,633 | ) | |||
The following is a summary of the Companys outstanding common stock warrants as of March 31,
2011 and December 31, 2010:
Number of Warrants outstanding as of: | ||||||||||||||||
Weighted Average | (in thousands) | |||||||||||||||
Warrants Issued in Connection with: | Date of Issue | Exercise Price | March 31, 2011 | December 31, 2010 | ||||||||||||
Committed Equity
Financing Facility |
February 19, 2008 | $ | 54.80 | 13 | 13 | |||||||||||
Direct Registration
Series I Warrants |
July 20, 2009 | $ | 42.00 | 141 | 141 | |||||||||||
Private Placement Series
A Warrants |
March 11, 2010 | $ | 5.60 | | 1,536 | |||||||||||
Private Placement Series
C Warrants |
March 11, 2010 | $ | 5.60 | | 1,229 | |||||||||||
Total Warrants outstanding |
154 | 2,919 | ||||||||||||||
Note that as of December 31, 2010, the Committed Equity Financing Facility warrants were
accounted for as a liability. Effective with the PIPE Warrant exchange agreement, these warrants
have been reclassified as equity. See full discussion below regarding warrant activity during the
three month period ended March 31, 2011.
Private Issuance of Public Equity PIPE Warrants
On March 11, 2010, the Company completed a definitive agreement with certain institutional
investors to sell shares of its common stock and four separate series of warrants to purchase
common stock in a private placement. Gross proceeds of the financing were approximately
$7,500,000, before deducting placement agent fees and estimated offering expenses, and excluding
the subsequent exercises of the warrants.
The four separate series of warrants consisted of the following:
(A) Series A Warrants to initially purchase 328,947 shares of common stock, which were
exercisable immediately after issuance, had a 5-year term and had an initial per share exercise
price of $30.40;
(B) Series B Warrants to initially purchase 328,947 shares of common stock, which were
initially exercisable at a per share exercise price of $22.80, on the earlier of the six month
anniversary of the closing date or the date on which the Companys stockholders approve the
issuance of shares in the transaction, and expired on the later of three months from the effective
date of the resale registration statement covering such shares and seven months from the closing
date. These warrants expired on October 12, 2010;
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(C) Series C Warrants to initially purchase 328,947 shares of common stock, and which would be
exercisable upon the exercise of the Series B Warrants and on the earlier of the six month
anniversary of the closing date or the date on which the Companys stockholders approve the
issuance of shares in the transaction, would expire five years after the date on which they become
exercisable, and had an initial per share exercise price of $22.80; and
(D) Series D Warrants to purchase shares of common stock. The Series D Warrants were not
immediately exercisable. The Company registered for resale 337,757 shares of common stock issuable
upon exercise of the Series D Warrants pursuant to an agreement with the warrant holders. All of
the Series D Warrants were exercised by November 4, 2010 and there are no Series D Warrants
outstanding after that date.
The Series A, B and C warrants listed above contained full ratchet anti-dilution features
based on the price and terms of any financings completed after March 11, 2010 as described in the
warrant agreements. All of the warrants listed above contained a cashless exercise feature as
described in the warrant agreements.
The Company determined that in accordance with Accounting Standards Codification (ASC) 480,
Distinguishing Liabilities from Equity, the Series A, B, and C warrants qualify for treatment as
liabilities due to provisions of the related warrant agreements that call for the number of
warrants and their exercise price to be adjusted in the event that the Company issues additional
shares of common stock, options or convertible instruments at a price that is less than the initial
exercise price of the warrants. The Company also determined that, in accordance with ASC 815,
Derivatives and Hedging, the Series D Warrants meet the definition of a derivative. The issuance
date fair market value of the Series A, B, C and D warrants of $11,868,000 was recorded as a
liability. The approximately $4,933,000 excess of the fair value of the liability recorded for
these warrants over the net proceeds received was recorded as a charge to earnings and is included
in Change in fair value of warrants and other financial instruments within the Statement of
Operations. Changes in the fair market value from the date of issuance to the exercise date and
reporting date, until exercised or cancelled will be recorded as a gain or loss in the statement of
operations.
As of December 31, 2010, all Series B and D warrants had either been exercised or expired.
On January 18, 2011, OXiGENE, entered into separate Warrant Exchange Agreements with each
of the holders of Series A and Series C warrants to purchase shares of common stock, issued in
March 2010, pursuant to which, at the initial closing, the warrant holders exchanged their
outstanding Series A and Series C warrants having ratchet price-based anti-dilution
protections for (A) an aggregate of 1,096,933 shares of common stock and (B) Series E Warrants
to purchase an aggregate of 1,222,623 shares of common stock. The Series E Warrants were not
exercisable for six months, had an exercise price of $4.60 per share (reflecting the market
value of the shares of common stock as of the close of trading on January 18, 2011, prior to the
entry into the Warrant Exchange Agreements), and did not contain any price-based anti-dilution
protections. In addition, the Company agreed to seek shareholder approval to issue, in exchange
for the Series E Warrants, up to 457,544 additional shares of common stock to the warrant
holders in a subsequent closing. The Series E Warrants were accounted for as a liability from
the date of issuance to the date of exchange, all of which occurred during the three month
period ended March 31, 2011. The initial closing occurred on January 20, 2011, and the
subsequent closing took place on March 21, 2011, following the stockholder meeting on March 18,
2011. The Company determined that in accordance with Accounting Standards Codification (ASC)
480, Distinguishing Liabilities from Equity, the Series E warrants qualify for treatment as a
liability during the period that they were outstanding due to provisions of the related warrant
agreement that allow for the warrants to be net settled in shares of the Companys common stock
under certain circumstances as described in the agreement. As a result, there were no Series A,
Series C or Series E warrants outstanding as of March 31, 2011.
On January 20, 2011, the date of the initial closing, the Company marked the existing
Series A and C warrants to market at a combined fair value of $6,633,000. These warrants were
exchanged for Series E warrants, valued at $1,555,000, and shares of common stock valued at
$4,388,000. The difference between these items was recorded as a gain on the transaction of
$690,000. On the date of the subsequent closing, the fair value of the Series E warrants was
equal to the value of the 457,544 shares of common stock issued in the exchange, and therefore
there was no gain or loss on the transaction.
The table below summarizes the factors used to determine the value of the Series A and C
warrants outstanding during the three month period ended March 31, 2011. The Company established
the fair value of the Series A, and C warrants using the Black-Scholes option valuation model:
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Warrant Valuation on date of Warrant Exchange
January 19, 2011
January 19, 2011
Total Fair | ||||||||||||
Series A | Series C | Market Value | ||||||||||
Stock Price |
$ | 4.32 | $ | 4.32 | ||||||||
Exercise Price |
$ | 5.60 | $ | 5.60 | ||||||||
Contractual life (in Years) |
4.1 years | 4.5 years | ||||||||||
Expected volatility |
82 | % | 79 | % | ||||||||
Risk-free interest rate |
1.53 | % | 1.68 | % | ||||||||
Fair market value (in thousands) |
$ | 3,663 | $ | 2,970 | $ | 6,633 | ||||||
Warrant Valuation as of
December 31, 2010
December 31, 2010
Total Fair | ||||||||||||
Series A | Series C | Market Value | ||||||||||
Stock Price |
$ | 4.60 | $ | 4.60 | ||||||||
Exercise Price |
$ | 5.60 | $ | 5.60 | ||||||||
Contractual life (in Years) |
4.2 years | 4.5 years | ||||||||||
Expected volatility |
81 | % | 80 | % | ||||||||
Risk-free interest rate |
2.01 | % | 2.01 | % | ||||||||
Fair market value (in thousands) |
$ | 4,143 | $ | 3,355 | $ | 7,498 | ||||||
Management determined the fair value of the Series E Warrants on the date of the initial
closing to be $1,555,000. This fair value was estimated based upon the $4.00 per share fair value
of the 457,544 shares of common stock expected to be exchanged for the Series E Warrants upon
shareholder approval adjusted for a 15% discount for lack of marketability which existed until the
expected shareholder vote. Management determined the fair value of the Series E warrants on the
date of the subsequent closing to be $993,000. This fair value was estimated based upon the $2.17
per share fair value of the 457,544 shares of common stock exchanged for the Series E Warrants.
Committed Equity Financing Facility (CEFF) with Kingsbridge Capital Limited
In February 2008, OXiGENE entered into a Committed Equity Financing Facility (CEFF) with
Kingsbridge Capital Limited (Kingsbridge), which was subsequently amended in February 2010 to
increase the commitment period, increase the draw down discount price and increase the maximum draw
period.
Under the terms of the amended CEFF, Kingsbridge committed to purchase, subject to certain
conditions, up to 285,401 shares of the Companys common stock during the period which ends May 15,
2012. Under the CEFF, OXiGENE is able to draw down in tranches of the lesser of (i) $10,000,000 or
(ii) a maximum of 3.75 percent 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 is discounted between 5
and 14 percent 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
at prices below $0.75 per share or at a price below 85% of the closing share price of OXiGENE 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 12,500 shares of its common stock at a price of $54.80 per share
exercisable beginning six months after February 19, 2008 and for a period of five years thereafter.
As of March 31, 2011, there remain a total of 253,671 shares available for sale under the CEFF.
Due to the initially indeterminate number of shares of common stock underlying the warrants
issued in connection with the Companys private placement on March 11, 2010, OXiGENE concluded that
the CEFF warrants should be recorded as a liability
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effective with the date of the private placement. The fair value of the warrants on this date was reclassified from equity to derivative
liabilities. Changes in the fair market value from the date of the private placement to the
reporting date were recorded as a gain or loss in Change in fair value of warrants and other
financial instruments in the Statement of Operations. Effective with the warrant exchange
agreement executed in January 2011 in connection with the March 2010 private placement as described
above, the number of shares underlying the warrants issued in connection with the Companys private
placement was no longer indeterminable, and the CEFF warrants were reclassified to equity. The
Company revalued these warrants on the effective date of the exchange and recorded the gain in the
statement of operations. The Company established the fair value of the CEFF warrants using the
Black-Scholes option valuation model as reflected in the table below:
Warrant Valuation as of: | ||||||||
Date of Warrant | ||||||||
Exchange | ||||||||
January 19, 2011 | December 31, 2010 | |||||||
Stock Price |
$ | 4.32 | $ | 4.60 | ||||
Exercise Price |
$ | 54.80 | $ | 54.80 | ||||
Contractual life (in Years) |
2.6 years | 2.6 years | ||||||
Expected volatility |
87 | % | 96 | % | ||||
Risk-free interest rate |
0.82 | % | 1.02 | % | ||||
Fair market value (in thousands) |
$ | 3 | $ | 6 | ||||
Direct Registration Warrants
On July 20, 2009, OXiGENE raised approximately $10,000,000 in gross proceeds, before deducting
placement agents fees and other offering expenses, in a registered direct offering (the
Offering) relating to the sale of 312,500 units, each unit consisting of (i) one share of common
stock, (ii) a five-year warrant (Direct Registration Series I) to purchase 0.45 shares of common
stock at an exercise price of $42.00 per share of common stock and (iii) a short-term warrant
(Direct Registration Series II) to purchase 0.45 shares of common stock at an exercise price of
$32.00 per share of common stock (the Units). The short-term warrants expired on September 24,
2010 consistent with the terms of the warrant, without being exercised.
OXiGENE determined that the Direct Registration Series I warrant should be classified as a
liability as they require delivery of registered shares of common stock and thus could require
net-cash settlement in certain circumstances. Accordingly, these warrants were recorded as a
liability at their fair value as of the date of their issuance and are revalued at each subsequent
reporting date.
The fair value of the direct registration warrants was determined using the Black-Scholes
option valuation model applying the following assumptions:
Series I Warrant Valuation as of: | ||||||||
March 31, 2011 | December 31, 2010 | |||||||
Series I | Series I | |||||||
Stock Price |
$ | 1.76 | $ | 4.60 | ||||
Exercise Price |
$ | 42.00 | $ | 42.00 | ||||
Contractual life (in Years) |
3.3 years | 3.6 years | ||||||
Expected volatility |
91 | % | 86 | % | ||||
Risk-free interest rate |
1.29 | % | 1.02 | % | ||||
Fair market value (in thousands) |
$ | 17 | $ | 107 | ||||
Options
The Companys 2005 Stock Plan provides for the award of options, restricted stock and
stock appreciation rights to acquire up to 375,000 shares of the Companys common stock. This
number includes shares of its common stock, if any, that were subject to awards under the
Companys 1996 Plan as of the date of adoption of the 2005 Plan but which became or will
become unissued upon the cancellation, surrender or termination of such award. Currently, the
2005 Plan allows for awards of up to
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37,500 shares that may be granted to any participant in
any fiscal year. For options subject to graded vesting, the Company elected the straight-line
method of expensing these awards over the service period.
The following is a summary of the Companys stock option activity under its 1996 Plan and
2005 Plan for the three-month period ended March 31, 2011:
Weighted | ||||||||||||||||
Weighted | Average | |||||||||||||||
Average | Remaining | Aggregate | ||||||||||||||
Shares | Exercise Price | Contractual Life | Intrinsic Value | |||||||||||||
(In thousands) | (Years) | (In thousands) | ||||||||||||||
Options outstanding at December 31, 2010 |
326 | $ | 28.39 | 8.63 | ||||||||||||
Granted |
| |||||||||||||||
Exercised |
| |||||||||||||||
Forfeited and expired |
(13 | ) | $ | 17.79 | ||||||||||||
Options outstanding at March 31, 2011 |
313 | $ | 28.92 | 8.28 | ||||||||||||
Option exercisable at March 31, 2011 |
104 | $ | 48.10 | 6.79 | ||||||||||||
Options vested or expected to vest at March 31, 2011 |
184 | $ | 35.03 | 7.78 |
During the three months ended March 31, 2011, 1,000 options expired. As of March 31, 2011
there was approximately $790,000 of unrecognized compensation cost related to stock option
awards that is expected to be recognized as expense over a weighted average period of 2.7
years.
No stock options were granted during the three month periods ended March 31, 2011 and
2010.
Non-Vested Restricted Stock
As of March 31, 2011, the Company had 500 shares of non-vested restricted common stock
outstanding, issued at a grant price of $81.80.
The Company recorded contra expense of approximately $6,000 during the three month period
ended March 31, 2011 and expense of approximately $10,000 during the three months ended March
31, 2010 related to outstanding restricted stock awards. The 500 shares of unvested restricted
common stock at March 31, 2011 will vest in June 2011. 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 4 year
vesting period of the awards.
Employee Stock Purchase Plan (2009 ESPP)
In May 2009, the Companys stockholders approved the 2009 Employee Stock Purchase Plan
(the 2009 ESPP). Under the 2009 ESPP, employees have the option to purchase shares of the
Companys common stock at 85% of the closing price on the first day of each purchase period or
the last day of each purchase period (as defined in the 2009 ESPP), whichever is lower, up to
specified limits. Eligible employees are given the option to purchase shares of the Companys
common stock, on a tax-favored basis, through regular payroll deductions in compliance with
Section 423 of the Internal Revenue Code of 1986, as amended (the Code). Currently, an
aggregate of 125,000 shares of common stock may be issued under the 2009 ESPP, subject to
adjustment each year pursuant to the terms of the 2009 ESPP. The Company recorded expense
relating to the 2009 ESPP for the three month periods ended March 31, 2011 and 2010 of
approximately $1,000 and $2,000, respectively. Pursuant to the 2009 ESPP plan provisions, each
year beginning in 2010 there will be an annual increase in the number of shares available for
issuance under the ESPP on the first day of the new year in an amount equal to the lesser of:
25,000 shares or 5% of the shares of Common Stock outstanding on the last day of the preceding
fiscal year.
Director Compensation Policy
In December 2009, the Board of Directors approved the amended and restated policy which
established compensation to be paid to non- employee directors of the Company, to provide an
inducement to obtain and retain the services of qualified persons to serve as members of the
Companys Board of Directors. As a result of this plan, each of the Companys non-employee
Directors are granted 1,250 fully vested shares of common stock on both January 2 and July 1
of each year they are a director. The Company recorded expense for the three month periods
ended March 31, 2011 and 2010, of $35,000 and $100,000, respectively for these shares.
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5. Agreements
In July 2010, the Company entered into an at the market equity offering sales agreement
with McNicoll, Lewis & Vlak LLC, or MLV, pursuant to which it may issue and sell shares of its
common stock from time to time through MLV acting as its sales agent and underwriter. Sales of
the Companys common stock through MLV are made on the Companys principal trading market by
means of ordinary brokers transactions at market prices, in block transactions or as
otherwise agreed by MLV and the Company. MLV uses its commercially reasonable efforts to sell
the Companys common stock from time to time, based upon instructions from the Company
(including any price, time or size limits the Company may impose). The Company pays MLV a
commission rate of up to 7.0% of the gross sales price per share of any common stock sold
through MLV as agent under the sales agreement. The Company has also provided MLV with
customary indemnification rights
6. Net Loss Per Share
Basic and diluted net loss per share was calculated by dividing the net loss per share
attributed to OXiGENE shares of common stock by the weighted-average number of common shares
outstanding. All of the Companys common stock equivalents are anti-dilutive for all periods
in which the Company has reported a net loss. Accordingly, common stock equivalents of
approximately 466,000 and 1,366,000 at March 31, 2011 and 2010, respectively, were excluded
from the calculation of weighted average shares for diluted net loss per share.
7. Subsequent Event
From April 1, 2011 through May 2, 2011, the Company sold approximately 1,799,000 shares
of common stock pursuant to the ATM sales agreement resulting in net proceeds to the Company
of approximately $3,000,000.
The Company did not have any other material recognizable or unrecognizable subsequent
events that occurred after March 31, 2011 up through the date the Company issued these
financial statements.
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, 2011 and 2010 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, 2010, and also with the unaudited
financial statements set forth in Part I, Item 1 of this Quarterly Report on Form 10-Q.
Our Business
We are a clinical-stage, biopharmaceutical company developing novel therapeutics to treat
cancer and eye diseases. Our primary focus is the development of product candidates referred
to as vascular disrupting agents, or VDAs, that selectively
disable and destroy abnormal blood vessels that provide solid tumors a means of growth and
survival and also are associated with visual impairment in a number of ophthalmological
diseases and conditions. To date, more than 400 subjects have been treated with ZYBRESTAT, our
lead candidate, in human clinical trials, and the drug candidate has generally been observed
to be well-tolerated.
We expect cash on hand, plus the proceeds of our at-the-market equity offering sales agreement
received in April and May as described in this Quarterly Report on Form 10-Q, to fund our
operations through August 2011. If we are unable to access additional funds when needed, we
will not be able to continue the development of our product candidates and could be required
to delay, scale back or eliminate some or all of our development programs and other
operations. Such funding may not be available to us on acceptable terms, or at all. If we
fail to secure financing before the end of August 2011, we would be forced to cease all of our
clinical and other activities. Please see Liquidity and Capital Resources below for a more
detailed discussion of our liquidity. Any additional equity financing, which may not be
available to us or may not be available on favorable terms, most likely will be dilutive to
our current stockholders and debt financing, if available, may involve restrictive covenants.
If we access funds through collaborative or licensing arrangements, we may be required to
relinquish rights to some of our technologies or product candidates that we would otherwise
seek to develop or commercialize on our own, on terms that are not favorable to us. Our
ability to access capital when needed is not assured and, if not achieved on a timely basis,
will materially harm our business, financial condition and results of operations. These
conditions raise substantial doubt about our ability to continue as a going concern. The
Report of Independent Registered Public Accounting Firm at the beginning of the Consolidated
Financial Statements section in our Annual Report on Form 10-K for the year ended December 31,
2010 includes a going concern explanatory paragraph.
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ZYBRESTAT for Oncology
We are currently pursuing the development of ZYBRESTAT, a reversible tubulin binding
agent that works by disrupting the network of blood vessels, or vasculature, within tumors,
also referred to as vascular disruption. ZYBRESTAT selectively targets the existing abnormal
vasculature found specifically in most solid tumors and causes endothelial cells in that
vasculature to become round and block the flow of blood to the tumor. The downstream tumor
environment is then deprived of oxygen, and the resulting restriction in blood supply kills
the cells in the central portion of the tumor. Based on ZYBRESTATs positive activity observed
in animal models, we have conducted multiple clinical trials of ZYBRESTAT in a variety of
tumor types. Currently, we are pursuing clinical trials of ZYBRESTAT in patients with
anaplastic thyroid cancer (ATC), non-small cell lung cancer (NSCLC) and ovarian cancer.
FACT (fosbretabulin in anaplastic cancer of the thyroid) trial Phase 2/3 study with
ZYBRESTAT in anaplastic thyroid cancer (ATC)
In earlier Phase 1 studies of ZYBRESTAT in ATC, clinical investigators observed several
objective responses in treatment with ZYBRESTAT, including a complete response lasting more
than 13 years, in patients with ATC. A subsequent Phase 2 study in 26 ATC patients showed a
23% rate of one year survival in a disease where median expected survival of patients is
approximately 3-4 months from the time of diagnosis and fewer than 10% of patients are
typically alive at one year.
Based on this encouraging data, we completed a Special Protocol Assessment, or SPA,
process with the U.S. Food and Drug Administration, or FDA, in 2007, for a Phase 2/3 study,
which we refer to as the FACT trial, in which ZYBRESTAT was to be evaluated in 180 patients as
a potential treatment for ATC. ATC is a highly aggressive and lethal malignancy for which
there are currently no approved therapeutics and extremely limited treatment options.
ZYBRESTAT was awarded orphan drug status by the FDA and the European Commission in the
European Union for the treatment of advanced ATC and for the treatment of medullary, Stage IV
papillary and Stage IV follicular thyroid cancers. The FDA also granted Fast Track designation
to ZYBRESTAT for the treatment of regionally advanced and/or metastatic ATC.
The primary endpoint for the FACT trial is overall survival. Eligible patients with
histologically or cytologically confirmed ATC were randomized either to the treatment arm of
the study, in which they received ZYBRESTAT in combination with the chemotherapeutic agents
carboplatin and paclitaxel, or to the control arm of the study, in which they received only
carboplatin and paclitaxel. Central pathology review by external pathologists not associated
with the study was utilized to confirm the histological diagnosis.
The FACT trial began enrolling patients in 2007. A total of 40 clinical sites in 11
countries participated in this clinical study, which was conducted in accordance with good
clinical practice guidelines and the SPA. Due to the rarity of the disease and the fact that
most of the patients screened for the study either died or no longer met the trials inclusion
criteria, the enrollment period spanned more than twice the planned 18 month period. As a
result of both the length of the enrollment period and financial constraints affecting us, in
February 2010, we chose to continue to treat and follow all 80 patients who were enrolled in
the Phase 2/3 FACT clinical trial in ATC in accordance with the SPA, but to stop further
enrollment. Initial data from this trial was presented at both the 14th International Thyroid Congress on September 12, 2010 in Paris,
France and the 35th European Society of Medical Oncology Congress on October 11, 2010 in
Milan, Italy. At these meetings, we reported data suggesting a one-month benefit in overall
survival in patients receiving ZYBRESTAT in combination with chemotherapy. Of particular note
was the fact that the one year survival rate was more than doubled from 9% to 23% for patients
receiving chemotherapy plus ZYBRESTAT. The additional data we presented in October also
included some pre-defined subgroup analyses that confirmed the overall survival benefit
initially observed, and also indicated that ZYBRESTAT improved the survival of patients with
the most advanced stages of the disease, as well as patients who had been heavily pretreated
with surgery, radiation or chemotherapy. We expect to present data from an additional
event-driven survival analysis among the 80 enrolled patients at the American Society of
Clinical Oncology (ASCO) conference in June 2011.
The FDA has been informed that enrollment in this study was halted at 80 patients and
that we expected that the SPA would no longer be applicable. The orphan drug status and the
expedited review designations have not been affected by the halted enrollment in the Phase 2/3
study. On March 16, 2011, we met with the FDA to discuss the results of this study and a
potential path forward. The FDA indicated at the meeting that the data from the FACT trial are
suggestive of possible clinical activity that may warrant continued development, and that to
seek regulatory approval, we should plan to conduct an additional clinical trial with a
survival endpoint. The FDA also confirmed that, as we expected, the SPA that had been agreed
upon at the start of the study is no longer in effect.
FALCON (fosbretabulin in advanced lung oncology) trial randomized, controlled Phase 2
study with ZYBRESTAT in non-small cell lung cancer
We are currently evaluating ZYBRESTAT in a 63-patient, randomized, controlled Phase 2
clinical trial, which we refer to as the FALCON trial, as a potential first-line treatment for
non-small cell lung cancer, or NSCLC. In the FALCON trial, patients are
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randomized either to the treatment arm of the study, in which they receive ZYBRESTAT (CA4P) in combination with the
chemotherapeutic agents, carboplatin and paclitaxel, and bevacizumab, a drug that interferes
with blood vessel growth, or angiogenics, or to the control arm of the study, in which they
receive a standard combination regimen of carboplatin, paclitaxel and bevacizumab. We believe
that this study will suggest a benefit of ZYBRESTAT in NSCLC therapy. We further believe these
data could be used to design a pivotal registration program with ZYBRESTAT in NSCLC and more
generally, provide clinical validation supporting further evaluation of ZYBRESTAT in
combination with commonly used anti-angiogenic therapeutics that act by selectively inhibiting
a particular blood vessel growth path, namely, the vascular endothelial growth factor, or
VEGF, pathway.
We presented an update of the safety and clinical activity data for this trial at the
European Organization for Research and Treatment of Cancer symposium in November 2010 in
Berlin, Germany. The updated interim data showed that the median time to progression for
patients receiving ZYBRESTAT plus bevacizumab and chemotherapy was 9.5 months, compared with a
median time to progression of 8.8 months for patients receiving bevacizumab and chemotherapy
alone. Of the patients in the study arm (ZYBRESTAT combined with bevacizumab and
carboplatin/paclitaxel chemotherapy), 50% achieved a partial response, compared with the
control arm (bevacizumab and chemotherapy) of the trial, where only 38% of patients achieved a
partial response. The combination regimen including ZYBRESTAT was observed to be
well-tolerated with no significant cumulative toxicities when compared with the control arm of
the study. We expect to present the overall survival data from this study at the ASCO meeting
in June 2011.
ZYBRESTAT in ovarian cancer
On June 1, 2009, we reported positive final data from an investigator-sponsored Phase 2
study of ZYBRESTAT and carboplatin plus paclitaxel chemotherapy in patients with
platinum-resistant ovarian cancer at the 2009 ASCO Annual Meeting. Of 44 patients enrolled in
the study, 11 (25%) had confirmed partial responses as determined by the Gynecologic Cancer
Inter Group (GCIG) response criteria, i.e., response by tumor imaging (RECIST) and/or ovarian
cancer biomarker (CA-125) criteria. An additional 4 patients had unconfirmed partial
responses, and stable disease responses were reported in an additional 16 patients. The
combination regimen of ZYBRESTAT and carboplatin plus paclitaxel chemotherapy was observed to
be well-tolerated with approximately half of the patients completing all 6 cycles of therapy.
Based on the results of this Phase 2, single-arm, two-stage study, in February 2011, we
announced that we have entered into a Cooperative Research and Development Agreement (CRADA)
with the National Cancer Institutes (NCI) Cancer Therapy Evaluation Program (CTEP) to
collaborate on the conduct of a randomized Phase 2 trial of ZYBRESTAT in combination with
bevacizumab in up to 110 patients with relapsed, platinum-sensitive ovarian cancer. Under the
terms of the agreement, we will provide ZYBRESTAT to NCI for an NCI-sponsored study conducted
by the Gynecologic Oncology Group (GOG), an organization dedicated to clinical research in the
field of gynecologic cancer. The aim of the trial will be to determine if the combination of
ZYBRESTAT and bevacizumab will enhance anti-tumor effects and further delay tumor progression
when compared to bevacizumab alone. We anticipate that investigators will initiate enrollment
in this Phase 2 study in the first half of 2011. The primary endpoint of the study will be progression-free survival, with results
expected to become available in early 2013.
Possible areas for future development
We believe that, if successful, the ongoing ZYBRESTAT for oncology clinical trial program
will establish a compelling rationale for further development of ZYBRESTAT as a treatment for:
| aggressive and difficult-to-treat solid tumors; | ||
| use in combination with chemotherapy in a variety of solid tumors, particularly those in which carboplatin and/or paclitaxel chemotherapy are commonly used; and | ||
| use in combination with commonly used drugs, such as bevacizumab, that interfere with blood vessel growth, or angiogenics, in various solid tumor indications. |
We believe these areas for potential further development collectively represent a
significant unmet medical need and thus a significant potential commercial market opportunity
that includes cancers of the thyroid, ovary, kidney, liver, head and neck, breast, lung, skin,
brain, colon and rectum. Further development of our ongoing clinical trials will depend on
continuing analysis and results of these ongoing clinical studies and our cash resources at
that time.
OXi4503, a unique, second generation VDA for oncology indications
We are currently pursuing development of OXi4503, a second-generation, dual-mechanism
VDA, as a treatment for certain solid tumor types and, as a more recent development, for the
treatment of myeloid leukemias. We believe that OXi4503 is differentiated from other VDAs by
its dual-action activity: in addition to having potent vascular disrupting effects, OXi4503 is
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unique in that certain enzymes in the human body can help convert it to a form of chemical
that has direct tumor cell killing effects. We believe this unique property may result in
enhanced anti-tumor activity in certain tumor types as compared with other VDA drug
candidates. Based on data from preclinical studies, we believe that OXi4503 may have enhanced
activity in tumor types with relatively high levels of the enzymes that facilitate the
conversion of OXi4503 to the form of chemical that kills tumor cells. These tumor types
include hepatocellular carcinoma, melanoma, and leukemias of the myeloid lineage. In
preclinical studies, OXi4503 has shown potent anti-tumor activity against solid tumors and
acute myeloid leukemia models, both as a single agent and in combination with other cancer
treatment modalities.
We have completed a Phase 1 clinical trial of OXi4503 in patients with advanced solid
tumors sponsored by Clinical Research United Kingdom. In collaboration with us, Professor
Gordon Rustin and colleagues from the Mount Vernon Cancer Research Centre, UK and other
institutions in the United Kingdom, reported positive final data from this study at the 2010
ASCO Annual Meeting. In this study, 45 patients with advanced solid tumors who had declined or
were unresponsive to standard treatment were treated with escalating doses of OXi4503. Partial
responses were observed in two patients with epithelial ovarian cancer and stable disease was
observed in 9 patients. OXi4503 was also observed to be well-tolerated in this study. To date,
OXi4503 has been observed to have a manageable side-effect profile similar to that of other
agents in the VDA class, potential single-agent clinical activity, and effects on tumor blood
flow and tumor metabolic activity, as determined with several imaging modalities. We also
evaluated escalating doses of OXi4503 in an ongoing OXiGENE-sponsored Phase 1b trial,
initiated in the first quarter of 2009 in patients with solid tumors with hepatic involvement.
This study confirmed the recommended dose established in the first Phase 1 study. Patient
follow-up and final analysis of the data from the latter trial is ongoing.
Based on the results of preclinical studies published in the journal Blood in September
2010 that show OXi4503 has potent activity against acute myelogenous leukemia (AML) in animal
models, we entered into a clinical trial agreement pursuant to which investigators at the
University of Florida initiated an investigator sponsored Phase 1 study of OXi4503 in patients
with AML or myelodysplastic syndrome (MDS) in May of 2011. This open-label, dose-escalating
study for the treatment of up to 36 patients is being conducted in patients with relapsed or
refractory AML and MDS and will evaluate the safety profile, maximum tolerated dose and
biologic activity of OXi4503 in these patients. We expect that initial indications of biologic
activity from this study may be available as early as the first half of 2012.
The general direction of future development of OXi4503 solid tumors or hematologic
indications will depend on the outcome of the analysis of both the solid tumor studies and
the study in AML, as well as available financial resources and potential partnering
activities.
ZYBRESTAT for Ophthalmology
In addition to developing ZYBRESTAT as an intravenously administered therapy for oncology
indications, we have undertaken an ophthalmology research and development program with
ZYBRESTAT with the ultimate goal of developing a topical formulation of ZYBRESTAT for
ophthalmological diseases and conditions that are characterized by abnormal blood
vessel growth within the eye that result in loss of vision. Previously, we reported
results at the 2007 annual meeting of the Association for Research in Vision and
Ophthalmology, or ARVO, from a Phase 2 study in patients with myopic macular degeneration in
which all patients in the study met the primary clinical endpoint of vision stabilization at
three months after study entry.
In December 2010, we completed a randomized, double-masked, placebo-controlled Phase 2
proof-of-mechanism trial, which we refer to as the FAVOR trial, with a single dose of
intravenously-administered ZYBRESTAT in patients with polypoidal choroidal vasculopathy (PCV),
a form of choroidal neovascularization, which is a condition where new blood vessels form in
the choroid, a part of the eye, and which can lead to vision loss and, ultimately, blindness.
Current therapies, including approved drugs that interfere with blood vessel growth, known as
anti-angiogenics, appear to provide limited benefit. We believe that the architecture of the
abnormal vasculature in certain eye tissues, namely the retina and choroid, which contribute
to PCV patients loss of vision, may be particularly susceptible to treatment with a VDA such
as ZYBRESTAT.
We believe that PCV represents an attractive target indication and development pathway
for ZYBRESTAT. Unlike wet age-related macular degeneration, an indication for which several
anti-angiogenic drugs are approved or prescribed off-label, conducting clinical studies of
ZYBRESTAT in patients with ophthalmologic indications not yet approved for treatment with such
anti-angiogenic drugs could potentially prove to reduce development time and expense. The
objectives of the FAVOR trial and the ongoing preclinical program of ZYBRESTAT in
ophthalmology are:
| determine the therapeutic utility of ZYBRESTAT in PCV, and visualize the effect of ZYBRESTAT on the vasculature of the polyps associated with PCV; | ||
| determine blood concentrations of drug required for activity in humans and thereby estimate, with the benefit of preclinical data, an appropriate dose of topically-administered ZYBRESTAT to be evaluated in subsequent human clinical studies; and | ||
| further evaluate the feasibility of developing a topical formulation of ZYBRESTAT for ophthalmological indications. |
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Findings from the Phase 2 study, including effects on retinal thickness and retinal
bleeding, are expected to be presented at a future ophthalmology meeting.
We believe that a safe, effective and convenient topically-administered anti-vascular
therapeutic would have advantages over currently approved anti-vascular, ophthalmological
therapeutics, many of which must be injected directly into patients eyes, in some cases on a
chronic monthly basis.
For this purpose we have been developing a potential minitab topical formulation of
ZYBRESTAT which has demonstrated attractive pharmacokinetic and safety properties and efficacy
in destroying abnormal vasculature in a rat choroidal melanoma model following administration
in the eye. We believe that a topical formulation would enhance our partnering opportunities
to further develop ZYBRESTAT in diseases of the eye.
To date, we have completed preclinical testing that indicated that ZYBRESTAT has activity
in six different preclinical ophthalmology models, including a model in which ZYBRESTAT was
combined with an approved drug that interferes with blood vessel growth, or anti-angiogenic
agents. We have also completed multiple preclinical studies suggesting that ZYBRESTAT, when
applied topically to the surface of the eye at doses that appear to be well-tolerated,
penetrates to the retina and choroid in quantities that we believe should be sufficient for
therapeutic activity.
We are also evaluating the requirements for additional preclinical toxicology and
efficacy studies with ZYBRESTAT for topical ophthalmological formulations to better position
the program for partnering. Further development of this program will depend on the outcome of
our evaluation of these requirements and available financial resources.
Results of Operations
Three Months Ended March 31, 2011 and 2010
Revenue
We reported no licensing revenue for the three months ended March 31, 2011 and 2010. 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 in the near future unless we enter into a major licensing arrangement.
Costs and expenses
Summary
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, | ||||||||||||||||||||||||
2011 | 2010 | Increase (Decrease) | ||||||||||||||||||||||
% of Total | % of Total | |||||||||||||||||||||||
Operating | Operating | |||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | Amount | % | |||||||||||||||||||
Research and development |
$ | 1,683 | 55 | % | $ | 4,185 | 65 | % | $ | (2,502 | ) | -60 | % | |||||||||||
General and administrative |
1,385 | 45 | % | 1,703 | 27 | % | (318 | ) | -19 | % | ||||||||||||||
Restructuring |
510 | 8 | % | (510 | ) | -100 | % | |||||||||||||||||
Total operating expenses |
$ | 3,068 | 100 | % | $ | 6,398 | 100 | % | $ | (3,331 | ) | -52 | % | |||||||||||
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 March 31, | ||||||||||||||||||||||||
2011 | 2010 | Increase (Decrease) | ||||||||||||||||||||||
% of Total | % of Total | |||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | Amount | % | |||||||||||||||||||
External services |
$ | 859 | 51 | % | $ | 2,787 | 66 | % | $ | (1,928 | ) | -69 | % | |||||||||||
Employee compensation and related |
637 | 38 | % | 1,164 | 28 | % | (527 | ) | -45 | % | ||||||||||||||
Employee stock-based compensation |
48 | 3 | % | 35 | 1 | % | 13 | 37 | % | |||||||||||||||
Other |
139 | 8 | % | 199 | 5 | % | (60 | ) | -30 | % | ||||||||||||||
Total research and development |
$ | 1,683 | 100 | % | $ | 4,185 | 100 | % | $ | (2,502 | ) | -60 | % | |||||||||||
The reduction in external services expenses for the quarter ended March 31, 2011 compared
to the same three month period in 2010 is primarily attributable to a reduction in spending on
our ZYBRESTAT for Oncology program of approximately $2,000,000. This reduction is primarily
attributable to lower costs on our ATC study for the comparable periods in connection with our
decision to discontinue further recruitment of patients into this study in February 2010. In
addition, we experienced reductions in expenses for both our OXi4503 and ZYBRESTAT for
Ophthalmology programs for the comparable periods, primarily related to our decision in
February 2010 to scale back efforts in some of our projects in these areas as well.
The reduction in employee compensation and related expenses for the quarter ended March
31, 2011 compared to the same three month period of 2010 is due to a 43% reduction in our
average full time equivalents for the comparable periods. In February 2010 we implemented a
Company wide restructuring plan due to our decision to scale back activities in some of our
ongoing clinical projects.
The reduction in other expenses for the quarter ended March 31, 2011 compared to the same
three month period of 2010 is primarily due to a reduction in both our research and
development facility related costs as well as program wide support costs for the comparable
periods.
General and administrative expenses
The table below summarizes the most significant components of our general and
administrative expenses for the periods indicated, in thousands and as a percentage of total
general and administrative expenses. The table also provides the changes in these components
and their percentages:
Three Months ended March 31, | ||||||||||||||||||||||||
2011 | 2010 | Increase (Decrease) | ||||||||||||||||||||||
% of Total | % of Total | |||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | Amount | % | |||||||||||||||||||
Employee compensation and related |
$ | 489 | 36 | % | $ | 617 | 36 | % | $ | (128 | ) | -21 | % | |||||||||||
Employee stock-based compensation |
74 | 5 | % | 57 | 3 | % | 17 | 30 | % | |||||||||||||||
Consulting and professional services |
558 | 40 | % | 772 | 45 | % | (214 | ) | -28 | % | ||||||||||||||
Other |
264 | 19 | % | 257 | 16 | % | 7 | 3 | % | |||||||||||||||
Total general and administrative |
$ | 1,385 | 100 | % | $ | 1,703 | 100 | % | $ | (318 | ) | -19 | % | |||||||||||
The reduction in employee compensation and related expenses for the quarter ended
March 31, 2011 compared to the same three month period of 2010 is due to a reduction in our
average full time equivalents for the comparable periods of 25%. In February 2010 we
implemented a Company wide restructuring plan due to our decision to scale back activities in
some of our ongoing clinical projects.
The reduction in consulting and professional services expenses for the quarter ended
March 31, 2011 compared to the same three month period of 2010 is primarily due to a one time
cost incurred in the first quarter of 2010 in our attempt to acquire VaxGen Inc and due to
lower non-cash expense for director fees.
Restructuring Plan
In February 2010, we announced a restructuring plan designed to focus resources
on our highest-value clinical assets and reduce our cash utilization. We incurred a charge
of $510,000 in connection with this restructuring. Key aspects of the restructuring and
its effects on our current clinical trials were as follows:
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| We continue to advance our Phase 2 ZYBRESTAT trial in non-small cell lung cancer (FALCON study), with updated safety and efficacy results anticipated for presentation at the upcoming American Society of Clinical Oncology (ASCO) meeting in June 2011. | |
| We stopped further enrollment in the Phase 2/3 FACT clinical trial in anaplastic thyroid cancer (ATC), but have continued to treat and follow all patients who enrolled in the study. This approach has optimized our ability to gain useful additional insight into ZYBRESTATs antitumor activity earlier than the previously anticipated timeline, while also reducing cash utilization in 2010 and beyond. | |
| We discontinued enrolling patients in our OXi4503 Phase 1b trial in patients with hepatic tumors. We are evaluating the results received to date. | |
| We discontinued enrollment in our Phase 2 FAVOR study of ZYBRESTAT in polypoidal choroidal vasculopathy (PCV), a form of macular degeneration. | |
| Future development decisions concerning the OXi4503 program and the ZYBRESTAT for ophthalmology program will be made following these analyses and additional review by our management and board of directors. | |
| In addition, we reduced our workforce by 20 employees or approximately 49%. |
Other Income and Expenses
The table below summarizes Other Income and Expense in our Statements of Operations for
the three month periods ended March 31, 2011 and 2010, in thousands:
Three months ended March 31, | ||||||||
2011 | 2010 | |||||||
Change in fair value of warrants and other financial instruments |
$ | 2,210 | $ | (4,633 | ) | |||
Investment income |
1 | 7 | ||||||
Other expense, net |
(6 | ) | (4 | ) | ||||
Total |
$ | 2,205 | $ | (4,630 | ) | |||
We recorded an unrealized (non cash) gain in 2011 and loss in 2010 as a result
of the change in the estimated Fair Market Value (FMV) of our common stock warrants issued
in connection with the offerings of our common stock as discussed in the Warrants section of
Note 4 to the financial statements.
The table below summarizes the components of the change in fair value of warrants and
other financial instruments for the three month periods ended March 31, 2011 and 2010, in
thousands.
Three months ended March 31, | ||||||||
2011 | 2010 | |||||||
Committed Equity Financing Facility Warrants |
$ | 3 | $ | 2 | ||||
Direct Registration Warrants |
90 | 225 | ||||||
Excess of value of the Private Placement Warrants at issuance
over the net proceeds of the offering |
| (4,433 | ) | |||||
Gain recognized in connection with warrant exchange agreements |
690 | | ||||||
Private Placement Warrants |
1,427 | (427 | ) | |||||
Total gain (loss) on change in fair market value of derivatives |
$ | 2,210 | $ | (4,633 | ) | |||
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Liquidity and Capital Resources
To date, we have financed our operations principally through net proceeds received from
private and public equity financing and through our strategic development arrangement with
Symphony. We have experienced negative cash flow from operations each year since our
inception, except in fiscal 2000. As of March 31, 2011, we had an accumulated deficit of
approximately $208,563,000. We expect to continue to incur increased expenses, resulting in
losses, over at least the next several years due to, among other factors, our continuing and
planned clinical trials and anticipated research and development activities. We had cash, cash
equivalents and restricted cash of approximately $2,705,000 at March 31, 2011.
The following table summarizes our cash flow activities for the periods indicated, in
thousands:
Three months ended March 31, | ||||||||
2011 | 2010 | |||||||
Operating activities: |
||||||||
Net loss |
$ | (863 | ) | $ | (11,028 | ) | ||
Non-cash adjustments to net loss |
(2,012 | ) | 4,877 | |||||
Changes in operating assets and liabilities |
(710 | ) | (442 | ) | ||||
Net cash used in operating activities |
(3,585 | ) | (6,593 | ) | ||||
Investing activities: |
||||||||
Chang in other assets |
(12 | ) | 14 | |||||
Net cash (used in) provided by investing activities |
(12 | ) | 14 | |||||
Financing activities: |
||||||||
Proceeds from issuance of common stock |
1,625 | 6,661 | ||||||
Net cash provided by financing activities |
1,625 | 6,661 | ||||||
(Decrease) increase in cash and cash equivalents |
(1,972 | ) | 82 | |||||
Cash and cash equivalents at beginning of period |
4,602 | 13,932 | ||||||
Cash and cash equivalents at end of period |
$ | 2,630 | $ | 14,014 | ||||
Non-cash adjustments to net loss in the three month period ended March 31, 2011 consist
primarily of a gain from a change in the fair value of warrants and other financial
instruments of $2,210,000, offset in part by stock compensation expense of $157,000 related to
the issuance of options to purchase our common stock. The net change in operating assets and
liabilities is primarily attributable to a decrease in accounts payable, accrued expenses and
other payables of $425,000 and an increase in prepaid expenses and other current assets of
$285,000. Net cash provided by financing activities for the three month period ended March 31,
2011 is primarily attributable to the sale of common stock under our at the market equity
financing facility discussed below.
In February 2010, we announced a restructuring of our clinical development programs. This
restructuring plan is designed to focus our resources on our highest-value clinical assets and
reduce our cash utilization. As a part of this restructuring we stopped further enrollment in
our Phase 2/3 anaplastic thyroid cancer clinical trial (FACT) and reduced our work force by
approximately 49% (20 employees). Further development of our ongoing clinical trials will
depend on upcoming analysis and results of these ongoing clinical studies and our cash
resources at that time.
This re-alignment of priorities in clinical programs together with the reduction in force
has resulted in a reduction in the cash required to operate our business by almost 50% on a
quarterly basis from the average $6,500,000 per quarter we experienced in the first half of
2010. We expect the continued reduction in our cash utilization from operations over the
course of 2011 as our current clinical projects reach completion.
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On March 11, 2010 we completed a definitive agreement with certain institutional
investors to sell shares of our Common Stock and four separate series of warrants to purchase
Common Stock in a private placement. Gross proceeds of the financing were approximately
$7,500,000, before deducting placement agent fees and estimated offering expenses, and
excluding the subsequent exercises of the warrants.
The four separate series of warrants consisted of the following:
(A) Series A Warrants to initially purchase 328,947 shares of common stock, which were
exercisable immediately after issuance, had a 5-year term and had an initial per share exercise
price of $30.40;
(B) Series B Warrants to initially purchase 328,947 shares of common stock, which were
initially exercisable at a per share exercise price of $22.80, on the earlier of the six month
anniversary of the closing date or the date on which the Companys stockholders approve the
issuance of shares in the transaction, and expired on the later of three months from the effective
date of the resale registration statement covering such shares and seven months from the closing
date. These warrants expired on October 12, 2010;
(C) Series C Warrants to initially purchase 328,947 shares of common stock, and which would be
exercisable upon the exercise of the Series B Warrants and on the earlier of the six month
anniversary of the closing date or the date on which the Companys stockholders approve the
issuance of shares in the transaction, would expire five years after the date on which they become
exercisable, and had an initial per share exercise price of $22.80; and
(D) Series D Warrants to purchase shares of common stock. The Series D Warrants were not
immediately exercisable. The Company registered for resale 337,757 shares of common stock issuable
upon exercise of the Series D Warrants pursuant to an agreement with the warrant holders. All of
the Series D Warrants were exercised by November 4, 2010 and there are no Series D Warrants
outstanding after that date.
The Series A, B and C warrants listed above contained full ratchet anti-dilution features
based on the price and terms of any financings completed after March 11, 2010 as described in the
warrant agreements. All of the warrants listed above contained a cashless exercise feature as
described in the warrant agreements.
We determined that in accordance with Accounting Standards Codification (ASC) 480,
Distinguishing Liabilities from Equity, the Series A, B, and C warrants qualify for treatment as
liabilities due to provisions of the related warrant agreements that call for the number of
warrants and their exercise price to be adjusted in the event that we issue additional shares of
common stock, options or convertible instruments at a price that is less than the initial exercise
price of the warrants. We also determined that, in accordance with ASC 815, Derivatives and
Hedging, the Series D Warrants meet the definition of a derivative. The issuance date fair market
value of the Series A, B, C and D warrants of $11,868,000 was recorded as a liability. The
approximately $4,433,000 excess of the fair value of the liability recorded for these warrants over
the net proceeds received was recorded as a charge to earnings and is included in Change in fair
value of warrants and other financial instruments within the Statement of Operations. Changes in
the fair
market value from the date of issuance to the exercise date and reporting date, until
exercised or cancelled will be recorded as a gain or loss in the statement of operations.
On January 18, 2011, we, entered into separate Warrant Exchange Agreements with each of the
holders of warrants to purchase shares of common stock, issued in March 2010, pursuant to which,
at the initial closing, the warrant holders exchanged their outstanding Series A and Series C
warrants having ratchet price-based anti-dilution protections for (A) an aggregate of
1,096,933 shares of common stock and (B) Series E Warrants to purchase an aggregate of 1,222,623
shares of common stock. The Series E Warrants were not exercisable for six months, had an
exercise price of $4.60 per share (reflecting the market value of the shares of common stock as
of the close of trading on January 18, 2011, prior to the entry into the Warrant Exchange
Agreements), and did not contain any price-based anti-dilution protections. In addition, we
agreed to seek shareholder approval to issue, in exchange for the Series E Warrants, up to
457,544 additional shares of common stock to the warrant holders in a subsequent closing. The
Series E Warrants were accounted for as a liability from the date of issuance to the date of
exchange, all of which occurred during the three month period ended March 31, 2011. The initial
closing occurred on January 20, 2011, and the subsequent closing took place on March 21, 2011,
following the stockholder meeting on March 18, 2011.
In July 2010, we entered into an at the market (ATM) equity offering sales agreement with
McNicoll, Lewis & Vlak LLC, or MLV, pursuant to which we may issue and sell shares of our common
stock from time to time through MLV acting as our sales agent and underwriter. Sales of our
common stock through MLV are made on the principal trading market of our common stock by means
of ordinary brokers transactions at market prices, in block transactions or as otherwise agreed
by MLV and us. MLV uses its commercially reasonable efforts to sell our common stock from time
to time, based upon our instructions (including any price, time or size limits we may impose).
We pay MLV a commission rate of up to 7.0% of the gross sales price per share of any common
stock sold through MLV as agent under the sales agreement. We have also provided MLV with
customary indemnification rights.
During the three months ended March 31, 2011, we sold 677,000 shares of common stock
pursuant to the sales agreement resulting in net proceeds to us of approximately $1,625,000.
From April 1, 2011 through May 2, 2011, we sold approximately
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1,799,000 shares of common stock
pursuant to the ATM sales agreement resulting in net proceeds to the Company of approximately
$3,000,000. With the sale of shares under the ATM in April and May 2011, we have sold the
maximum amount allowed under our prospectus supplement to Form S-3 dated January 31, 2011. No
assurance can be given that we will sell any additional shares under the ATM sales agreement,
or, if we do, as to the price or amount of shares that we will sell, or the dates on which any
such sales will take place.
We will need to access additional funds to remain a going concern beyond August 2011.
Including net proceeds from the sale of shares in April and May 2011 under the ATM sales
agreement described above, we expect that our financial resources will be sufficient to fund our
operations through August of 2011. We are aggressively pursuing other forms of capital infusion
including public or private financing, strategic partnerships or other arrangements with
organizations that have capabilities and/or products that are complementary to our own
capabilities and/or products, in order to continue the development of our product candidates. If
we are unable to access additional funds when needed, we would not be able to continue the
development of our product candidates or we could be required to delay, scale back or eliminate
some or all of our development programs and other operations. Any additional equity financing,
which may not be available to us or may not be available on favorable terms, may be dilutive to
our current stockholders and debt financing, if available, may involve restrictive covenants. If
we access funds through collaborative or licensing arrangements, we may be required to
relinquish rights to some of our technologies or product candidates that we would otherwise seek
to develop or commercialize on our own, on terms that are not favorable to us. Our ability to
access capital when needed is not assured and, if not achieved on a timely basis, will
materially harm our business, financial condition and results of operations. This uncertainty
creates doubt about our ability to continue as a going concern.
Our cash utilization amount is highly dependent on the progress of our potential-product
development programs, particularly, the results of our pre-clinical projects and clinical
trials, the cost, timing and outcomes of regulatory approvals for our product candidates, the
terms and conditions of our contracts with service providers for these programs, and 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. The
anticipated reduction in our cash utilization resulting from our restructuring plans is highly
dependent on the timeliness and effectiveness of renegotiating our contracts with the vendors
and service providers involved with the restructuring plans.
Our cash requirements may vary materially from those now planned for or anticipated by
management due to numerous risks and uncertainties. These risks and uncertainties include, but
are not limited to: the progress of and results of our pre-clinical testing and clinical trials
of our VDA drug candidates under development, including ZYBRESTAT, our lead drug candidate, and
OXi4503; the progress of our research and development programs; the time and costs expended and
required to obtain any necessary or desired regulatory approvals; the resources, if any, that we
devote to developing manufacturing 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.
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.
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, 2010 and in our notes to the financial statements set forth in Item 1 of
this Quarterly Report on Form 10-Q.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
At March 31, 2011, we did not hold any derivative financial instruments. As of March 31,
2011 we do not hold any commodity-based instruments or other long-term debt obligations. We
account for all of our other warrants issued in connection with our equity financings as
liabilities.
We have adopted an Investment Policy, the primary objectives of which are to preserve
principal, maintain proper liquidity to meet operating needs and maximize yields while
preserving principal. Although our investments are subject to credit risk, we follow
procedures to limit the amount of credit exposure in any single issue, issuer or type of
investment. Our investments are
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also subject to interest rate risk and will decrease in value
if market interest rates increase. However, due to the conservative nature of our investments
and relatively short duration, we believe that interest rate risk is mitigated. Our cash and
cash equivalents are maintained in U.S. dollar accounts. Although we conduct a number of our
trials and studies outside of the United States, we believe our exposure to foreign currency
risk to be limited as the arrangements are in jurisdictions with relatively stable currencies.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures.
The Securities and Exchange Commission, or SEC, requires that, as of the end of the
period covered by this Quarterly Report on Form 10-Q, the Chief Executive Officer (CEO) and
the Chief Financial Officer (CFO) evaluate the effectiveness of the design and operation of
our disclosure controls and procedures (as defined in Rule 13a-15(e)) under the Securities
Exchange Act of 1934, as amended, or the Exchange Act, and report on the effectiveness of the
design and operation of our disclosure controls and procedures. Based upon that evaluation,
our CEO and CFO concluded that our disclosure controls and procedures were effective to ensure
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 and is accumulated and communicated to our management, including our CEO and CFO, as
appropriate to allow timely decisions regarding required disclosure.
Changes in Internal Control.
There were no changes in our internal control over financial reporting, identified in
connection with the evaluation of such control that occurred during the last fiscal quarter,
which have materially affected, or are reasonably likely to materially affect, our internal
control over financial reporting.
Important Considerations.
The effectiveness of our disclosure controls and procedures and our internal control over
financial reporting is subject to various inherent limitations, including cost limitations,
judgments used in decision making, assumptions about the likelihood of future events, the
soundness of our systems, the possibility of human error, and the risk of fraud. Moreover,
projections of any evaluation of effectiveness to future periods are subject to the risk that
controls may become inadequate because of changes in conditions and the risk that the degree
of compliance with policies or procedures may deteriorate over time. Because of these
limitations, there can be no assurance that any system of disclosure controls and procedures
or internal control over financial reporting will be successful in preventing all errors or
fraud or in making all material information known in a timely manner to the appropriate levels
of management.
PART IIOTHER INFORMATION
Item 1. Legal Proceedings
None.
Item 1A. Risk Factors
Other than as set forth below, 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, 2010 filed with
the SEC.
We will be required to raise additional funds to finance our operations and remain a going
concern; we may not be able to do so when necessary, and/or the terms of any financings may not
be advantageous to us.
Our operations to date have consumed substantial amounts of cash. Negative cash flows from
our operations are expected to continue over at least the next several years. Our cash
utilization amount is highly dependent on the progress of our product development programs,
particularly, the results of our preclinical and clinical studies, the cost, timing and outcomes
of regulatory approval for our product candidates, the terms and conditions of our contracts with
service providers for these programs, and the rate of recruitment of patients in our human
clinical trials.
In addition, the further development of our ongoing clinical trials will depend on upcoming
analysis and results of those studies and our cash resources at that time.
We expect cash on hand to fund our operations through August 2011. In order to remain a
going concern beyond August 2011, we will require significant funding. Additional funds to
finance our operations may not be available on terms that we deem acceptable, or at all. If we
fail to secure financing before the end of August 2011, we would be forced to cease all of our
clinical and other activities.
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Our ongoing capital requirements will depend on numerous factors, including: the progress
and results of preclinical testing and clinical trials of our product candidates under
development, including ZYBRESTAT 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 develop 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 against possible claims of infringement by third-party
patent or other technology rights; the cost of commercialization activities and arrangements, if
any, undertaken by us; and, if and when approved, the demand for our products, which demand
depends in turn on circumstances and uncertainties that cannot be fully known, understood or
quantified unless and until the time of approval, including the range of indications for which
any product is granted approval.
If we are unable to raise additional funds when needed, we will not be able to continue
development of our product candidates or we will be required to delay, scale back or eliminate
some or all of our development programs or cease operations. We may seek to raise additional
funds through public or private financing, strategic partnerships or other arrangements. Any
additional equity financing may be dilutive to our current stockholders and debt financing, if
available, may involve restrictive covenants. If we raise funds through collaborative or
licensing arrangements, we may be required to relinquish, on terms that are not favorable to us,
rights to some of our technologies or product candidates that we would otherwise seek to develop
or commercialize. Our failure to raise capital when needed will materially harm our business,
financial condition and results of operations. These conditions raise substantial doubt about our
ability to continue as a going concern. The Report of Independent Registered Public Accounting
Firm at the beginning of the Consolidated Financial Statements section of our Annual Report on
Form 10-K for the year ended December 31, 2010 includes a going concern explanatory paragraph.
We face the potential delisting of our common stock from the NASDAQ Capital Market due to the
uncertainty of our ability to achieve compliance with certain continued listing requirements by
June 13, 2011 . If we are unable to meet these requirements, we could be required to list our
common stock in the over-the-counter market, which could make obtaining future financing more
difficult.
Prior to March 3, 2011, the Companys stock was listed on the NASDAQ Global Market.
Companies listed on The NASDAQ Stock Market (NASDAQ) are subject to delisting for, among other
things, failure to maintain a minimum closing bid price per share of $1.00 for 30 consecutive
business days. On June 17, 2010, we received a letter from NASDAQ indicating that for the last 30
consecutive business days, the bid price of our common shares closed below the minimum $1.00 per
share requirement pursuant to NASDAQ Listing Rule 5450(a)(1) for continued inclusion on The
NASDAQ Global Market. In accordance with NASDAQ Listing Rule 5810(c)(3)(A), we had an initial
grace period of 180 calendar days, or until December 14, 2010, to regain compliance with the
minimum bid price requirement. In addition, companies listed on The NASDAQ Global Market are
subject to delisting for failure to maintain a minimum market value of $50,000,000 during any
consecutive 30 day period. On July 21, 2010, we received a letter from NASDAQ indicating that for
the last 30 consecutive business days, the market value of our common shares did not meet the
$50,000,000 minimum market value requirement pursuant to NASDAQ Listing Rule 5450(b)(A) for
continued inclusion on The
NASDAQ Global Market. In accordance with NASDAQ Listing Rule 5810(c)(3)(C), we had an initial
grace period of 180 calendar days, or until January 18, 2011, to regain compliance with the
minimum market value requirement. We did not regain compliance with the minimum bid price
requirement and the minimum market value requirement by December 14, 2010 and January 18, 2011,
respectively.
On March 1, 2011, a NASDAQ Stock Market Hearings Panel advised us of its decision to
transfer the listing of our common stock from The NASDAQ Global Market to The NASDAQ Capital
Market and continue our listing on that market, provided that we regain compliance by June 13,
2011 with all continued listing standards of The NASDAQ Capital Market and have evidenced a
closing bid price of $1.00 or more for a minimum of ten prior consecutive trading days. This
compliance deadline represents the full extent of the NASDAQ Stock Market Hearing Panels
authority to grant an exception and allow the continued listing of our common stock while we
remain deficient with respect to the continued listing standards. Should we be unable to timely
regain compliance with NASDAQs continued listing standards by June 13, 2011, the Hearings Panel
indicated it will issue a final determination to delist our common stock and suspend trading of
our common stock on The NASDAQ Stock Market, to be effective on the second business day from the
date of the final determination. On March 10, 2011, NASDAQ notified us that we regained
compliance with the minimum $1.00 per share closing bid price requirement for continued listing.
We must also regain compliance with the $35,000,000 minimum market value of listed securities
requirement or the minimum $2,500,000 stockholders equity requirement prior to June 13, 2011
or our common stock will be delisted from the NASDAQ Capital Market.
On April 6, 2011, we received written notification from NASDAQ that, as a result of Roy H.
Ficklings resignation from our board of directors, we no longer comply with NASDAQs independent
director and audit committee requirements as set forth in NASDAQ Listing Rules 5605(b)(1) and
5605(c)(2), respectively. The NASDAQ Listing Rules require that a majority of our board of
directors be composed of independent directors and that the audit committee of the board of
directors be composed of at least three independent directors. Pursuant to NASDAQ Listing Rules
5605(b)(1)(A) and 5605(c)(4), we have been provided with a cure period in order to regain
compliance as follows: until the earlier of our next annual shareholders meeting or March 31,
2012; or if the next
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annual shareholders meeting is held before September 27, 2011, then we must
evidence compliance no later than September 27, 2011. The nominating and governance committee of
our board is currently evaluating potential candidates to fill the vacancy on our board of
directors and is assessing the composition of its audit committee.
We cannot be sure that we will be able to timely regain compliance with The NASDAQ Stock
Markets listing standards. Neither can we be sure that we will comply with the requirements for
continued listing of our common shares on The NASDAQ Capital Market in the future. If our common
shares lose their status on The NASDAQ Capital Market, our common shares would likely trade in
the over-the-counter market.
If our shares were to trade on the over-the-counter market, selling our common shares could
be more difficult because smaller quantities of shares would likely be bought and sold,
transactions could be delayed, and security analysts coverage of us may be reduced. In addition,
in the event our common shares are delisted, broker-dealers have certain regulatory burdens
imposed upon them, which may discourage broker-dealers from effecting transactions in our common
shares, further limiting the liquidity of our common shares. These factors could result in lower
prices and larger spreads in the bid and ask prices for common shares.
Such delisting from The NASDAQ Capital Market and continued or further declines in our
share price and market value could also greatly impair our ability to raise additional
necessary capital through equity or debt financing, and could significantly increase the
ownership dilution to shareholders caused by our issuing equity in financing or other
transactions.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. (Removed and Reserved)
Item 5. Other Information
None.
Item 6. Exhibits
3.1
|
Certificate of Amendment of the Restated Certificate of Incorporation, dated February 22, 2011. (1) | |
4.1
|
Form of Series E Warrant. (2) | |
10.1
|
Form of Warrant Exchange Agreement, dated as of January 18, 2011, by and between the Company and each Investor named therein. (2) | |
10.2
|
Form of Voting Agreement, dated as of January 18, 2011, by and between the Company and each of its directors, executive officers and Symphony ViDA Holdings LLC. (2) | |
10.3
|
Form of Amendment No. 4 to Stockholder Rights Agreement, dated as of January 18, 2011, by and between the Company and American Stock Transfer & Trust Company, LLC. (2) | |
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. |
(1) | Incorporated by reference to the Registrants Current Report on Form 8-K, filed on February 22, 2011. | |
(2) | Incorporated by reference to the Registrants Current Report on Form 8-K, filed on January 19, 2011. |
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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 13, 2011 | By: | /s/ Peter J. Langecker | ||
Peter J. Langecker | ||||
Chief Executive Officer | ||||
Date: May 13, 2011 | By: | /s/ James B. Murphy | ||
James B. Murphy | ||||
Vice President and Chief Financial Officer | ||||
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EXHIBIT INDEX
3.1
|
Certificate of Amendment of the Restated Certificate of Incorporation, dated February 22, 2011. (1) | |
4.1
|
Form of Series E Warrant. (2) | |
10.1
|
Form of Warrant Exchange Agreement, dated as of January 18, 2011, by and between the Company and each Investor named therein. (2) | |
10.2
|
Form of Voting Agreement, dated as of January 18, 2011, by and between the Company and each of its directors, executive officers and Symphony ViDA Holdings LLC. (2) | |
10.3
|
Form of Amendment No. 4 to Stockholder Rights Agreement, dated as of January 18, 2011, by and between the Company and American Stock Transfer & Trust Company, LLC. (2) | |
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. |
(1) | Incorporated by reference to the Registrants Current Report on Form 8-K, filed on February 22, 2011. | |
(2) | Incorporated by reference to the Registrants Current Report on Form 8-K, filed on January 19, 2011. |
31