Oncotelic Therapeutics, Inc. - Quarter Report: 2011 June (Form 10-Q)
Table of Contents
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 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 incorporation or organization) |
(I.R.S. Employer 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 þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act.
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 August 5, 2011, there were 14,355,329 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.
2
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EX-101 CALCULATION LINKBASE DOCUMENT | ||||||||
EX-101 LABELS LINKBASE DOCUMENT | ||||||||
EX-101 PRESENTATION LINKBASE DOCUMENT | ||||||||
EX-101 DEFINITION LINKBASE DOCUMENT |
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PART IFINANCIAL INFORMATION
Item 1. Financial StatementsUnaudited
OXiGENE, Inc.
Condensed Balance Sheets
(All amounts in thousands, except per share data)
(Unaudited)
(All amounts in thousands, except per share data)
(Unaudited)
June 30, 2011 | December 31, 2010 | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 8,460 | $ | 4,602 | ||||
Restricted cash |
40 | 75 | ||||||
Prepaid expenses |
396 | 256 | ||||||
Other current assets |
86 | 75 | ||||||
Total current assets |
8,982 | 5,008 | ||||||
Furniture and fixtures, equipment and leasehold improvements |
836 | 1,512 | ||||||
Accumulated depreciation |
(781 | ) | (1,425 | ) | ||||
55 | 87 | |||||||
License agreements, net of accumulated amortization of $1,163 and $1,114 at
June 30, 2011 and December 31, 2010, respectively |
337 | 386 | ||||||
Other assets |
86 | 86 | ||||||
Total assets |
$ | 9,460 | $ | 5,567 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT) |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 440 | $ | 458 | ||||
Accrued research and development |
1,169 | 2,125 | ||||||
Accrued other |
581 | 628 | ||||||
Total current liabilities |
2,190 | 3,211 | ||||||
Derivative liability long term |
48 | 7,611 | ||||||
Total liabilities |
2,238 | 10,822 | ||||||
Commitments and contingencies |
||||||||
Stockholders equity (deficit) |
||||||||
Preferred Stock, $.01 par value, 15,000 shares authorized; 0 shares issued and
outstanding at June 30, 2011 and December 31, 2010 |
| | ||||||
Common stock, $.01 par value, 300,000 shares authorized and 11,687 shares
issued and outstanding at June 30, 2011; 300,000 shares authorized and 5,501
shares issued and outstanding at December 31, 2010 |
117 | 55 | ||||||
Additional paid-in capital |
218,600 | 202,390 | ||||||
Accumulated deficit |
(211,495 | ) | (207,700 | ) | ||||
Total stockholders equity (deficit) |
7,222 | (5,255 | ) | |||||
Total liabilities and stockholders equity (deficit) |
$ | 9,460 | $ | 5,567 | ||||
See accompanying notes.
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OXiGENE, Inc.
Condensed Statements of Operations
(All amounts in thousands, except per share data)
(Unaudited)
(All amounts in thousands, except per share data)
(Unaudited)
Three months ended June 30, | Six months ended June 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Operating costs and expenses(1) : |
||||||||||||||||
Research and development |
$ | 1,499 | $ | 3,348 | $ | 3,182 | $ | 7,533 | ||||||||
General and administrative |
1,401 | 1,678 | 2,786 | 3,381 | ||||||||||||
Restructuring |
| | | 510 | ||||||||||||
Total operating costs and expenses |
2,900 | 5,026 | 5,968 | 11,424 | ||||||||||||
Loss from operations |
(2,900 | ) | (5,026 | ) | (5,968 | ) | (11,424 | ) | ||||||||
Change in fair value of warrants and other financial
instruments |
(31 | ) | 7,539 | 2,179 | 2,906 | |||||||||||
Investment income |
1 | 4 | 2 | 11 | ||||||||||||
Other (expense) income, net |
(2 | ) | 20 | (8 | ) | 16 | ||||||||||
Net (loss) income |
$ | (2,932 | ) | $ | 2,537 | $ | (3,795 | ) | $ | (8,491 | ) | |||||
Basic and diluted net (loss) income per share |
$ | (0.32 | ) | $ | 0.73 | $ | (0.49 | ) | $ | (2.54 | ) | |||||
Weighted-average number of common shares
outstanding Basic and diluted |
9,110 | 3,477 | 7,820 | 3,348 | ||||||||||||
(1) Includes share based compensation expense as follows: |
||||||||||||||||
Research and development |
$ | 118 | $ | 13 | $ | 166 | $ | 47 | ||||||||
General and administrative |
211 | 270 | $ | 320 | $ | 427 | ||||||||||
Total share based compensation expense |
$ | 329 | $ | 283 | $ | 486 | $ | 474 | ||||||||
See accompanying notes.
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OXiGENE, Inc.
Condensed Statements of Cash Flows
(All amounts in thousands)
(Unaudited)
(All amounts in thousands)
(Unaudited)
Six months ended June 30, | ||||||||
Operating activities: | 2011 | 2010 | ||||||
Net loss |
$ | (3,795 | ) | $ | (8,491 | ) | ||
Adjustments to reconcile net loss to net cash used in operating
activities: |
||||||||
Change in fair value of warrants and other financial instruments |
(2,179 | ) | (2,906 | ) | ||||
Depreciation |
32 | 55 | ||||||
Amortization of license agreement |
49 | 49 | ||||||
Stock-based compensation |
486 | 474 | ||||||
Changes in operating assets and liabilities: |
||||||||
Restricted cash |
35 | 65 | ||||||
Prepaid expenses and other current assets |
(151 | ) | 46 | |||||
Accounts payable, accrued expenses and other payables |
(1,015 | ) | (2,700 | ) | ||||
Net cash used in operating activities |
(6,538 | ) | (13,408 | ) | ||||
Investing activities: |
||||||||
Changes in other assets |
| 38 | ||||||
Net cash provided by investing activities |
| 38 | ||||||
Financing activities: |
||||||||
Proceeds from issuance of common stock, net of acquisition costs |
10,396 | 6,652 | ||||||
Proceeds from exercise of employee stock plans |
| 23 | ||||||
Net cash provided by financing activities |
10,396 | 6,675 | ||||||
(Decrease) increase in cash and cash equivalents |
3,858 | (6,695 | ) | |||||
Cash and cash equivalents at beginning of period |
4,602 | 13,932 | ||||||
Cash and cash equivalents at end of period |
$ | 8,460 | $ | 7,237 | ||||
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
June 30, 2011
(Unaudited)
June 30, 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 and six months ended June 30,
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 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 has paid 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 six months ended June 30, 2011, the Company sold approximately 4,623,000
shares of common stock pursuant to the ATM sales agreement resulting in net proceeds to the
Company of approximately $10,396,000. From July 1, 2011 through August 5, 2011, the Company
sold approximately 2,665,000 shares of common stock pursuant to the ATM sales agreement
resulting in net proceeds to the Company of approximately $6,032,000. On July 8, 2011, the
Company filed a prospectus supplement to Form S-3 with the SEC which allows it to offer shares
of its common stock having an aggregate offering price of up to $3,100,000 pursuant to the ATM
sales agreement. With the sale of shares under the ATM through August 5, 2011, there remains a
total of approximately $751,000 in net proceeds of the maximum amount allowed under the
Companys prospectus supplement to Form S-3 dated July 8, 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.
Together with the net proceeds received in the third quarter 2011 through August 5, 2011
under the July 2011 prospectus supplement and as a result of its expectation that its
operating and investing cash outflows will continue to decline, the Company expects that its
cash resources will be sufficient to fund its operations through the end of fiscal 2012,
however, 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, will likely 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. As a result of this uncertainty and the substantial doubt about the Companys ability to
continue as a going concern as of December 31, 2010, the Report of Independent Registered
Public Accounting Firm at the beginning of the Consolidated Financial Statements section in
the Companys Annual Report on Form 10-K for the year ended December 31, 2010 includes a going concern
explanatory paragraph. If the Company is unable to access additional funds in the
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future, it is likely that the Companys 2011 Report of Independent
Registered Public Accounting Firm will also include a going concern explanatory
paragraph.
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:
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 June 30, 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 June 30, 2011 and
December 31, 2010, OXiGENE held $8,500,000 and $4,677,000 in cash, cash equivalents and
restricted cash, respectively. The Company has adopted the fair value standard 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
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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) 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).
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. 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 OXiGENE 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. During the second quarter of 2011, $676,000 in
fully depreciated assets, primarily consisting of leasehold improvements which were no longer
in use, have been written off.
Property and equipment consisted of the following at the dates indicated below:
June 30, 2011 | December 31, 2010 | |||||||
(in thousands) | ||||||||
Leasehold improvements |
$ | 25 | $ | 449 | ||||
Equipment |
598 | 647 | ||||||
Furniture and fixtures |
213 | 416 | ||||||
Total gross assets |
836 | 1,512 | ||||||
Less accumulated depreciation |
(781 | ) | (1,425 | ) | ||||
Total property and equipment |
$ | 55 | $ | 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 June 30, 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.
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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 June 30, 2011 and
December 31, 2010, was approximately $337,000 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 have 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.
4. Stockholders Equity (Deficit), Common and Preferred Shares
The Company had 300,000,000 shares of common stock authorized as of June 30, 2011 and
December 31, 2010. As of June 30, 2011, the Company had approximately 11,687,000 shares of
common stock issued and outstanding.
In July 2010, the Company entered into an at the market (ATM) equity offering sales
agreement with 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 has paid 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 six months ended June 30, 2011, the Company sold approximately 4,623,000 shares of
common stock pursuant to the ATM sales agreement resulting in net proceeds to the Company of
approximately $10,396,000. From July 1, 2011
through August 5, 2011, the Company sold approximately 2,665,000 shares of common stock
pursuant to the ATM sales agreement resulting in net proceeds to the Company of approximately
$6,032,000. Under our current prospectus supplement to Form S-3 dated July 8, 2011, there
remains approximately $751,000 in net proceeds available to be sold under the ATM arrangement.
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 a stockholder meeting on March 18, 2011. As a result, there were no Series A,
Series C or Series E warrants outstanding as of the subsequent closing date nor for any period
thereafter. 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
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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 six month period ended June 30, 2011:
Shares Issued in Connection with: | Shares Issued | Net Proceeds | ||||||
(in thousands) | ||||||||
Director fees |
8 | $ | | |||||
ATM |
4,623 | 10,396 | ||||||
Private Placement Warrant Exchange |
1,554 | | ||||||
Other |
1 | | ||||||
Totals |
6,186 | $ | 10,396 | |||||
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 six month period ended June 30, 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 six months ended June 30, 2011 (in thousands):
(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 |
(1,489 | ) | ||
Derivative liability outstanding at June 30, 2011 |
$ | 48 | ||
The table below summarizes the value of the warrant-related derivative liabilities
recorded on the Companys balance sheet (in thousands):
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As of June 30, 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 |
48 | 107 | ||||||
Private Placement Series A Warrants |
| 4,143 | ||||||
Private Placement Series C Warrants |
| 3,355 | ||||||
Total derivative liability |
$ | 48 | $ | 7,611 | ||||
The gain (loss) from the change in fair value of warrants and other financial instruments for
the three and six month periods ended June 30, 2011 and 2010 is summarized below (in thousands):
Three months ended June 30, | Six months ended June 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Committed Equity Financing Facility Warrants |
$ | | $ | 88 | $ | 3 | $ | 90 | ||||||||
Direct Registration Warrants |
(31 | ) | 1,753 | 59 | 1,978 | |||||||||||
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 |
| 5,698 | 1,427 | 5,271 | ||||||||||||
Total gain (loss) on change in fair market value of
derivatives |
$ | (31 | ) | $ | 7,539 | $ | 2,179 | $ | 2,906 | |||||||
The following is a summary of the Companys outstanding common stock warrants as of June
30, 2011 and December 31, 2010:
Number of Warrants outstanding as of: | ||||||||||||||||
Average Exercise | (in thousands) | |||||||||||||||
Warrants Issued in Connection with: | Date of Issue | Price | June 30, 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 Warrant Exchange described above, these warrants
have been reclassified as equity.
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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 approved 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 approved 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 first quarter of
fiscal 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. There were no Series A, Series C or Series E
warrants outstanding as of June 30, 2011.
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On January 20, 2011, the date of the initial closing of the Warrant Exchange Agreements,
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 six month period ended June 30, 2011. The Company established the
fair value of the Series A and C warrants using the Black-Scholes option valuation model:
Warrant Valuation on date of Warrant Exchange | ||||||||||||
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 | 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
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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 June 30, 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 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
agreements 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 warrants 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:
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Series I Warrant Valuation as of: | ||||||||
June 30, 2011 | December 31, 2010 | |||||||
Series I | Series I | |||||||
Stock Price |
$ | 2.48 | $ | 4.60 | ||||
Exercise Price |
$ | 42.00 | $ | 42.00 | ||||
Contractual life (in Years) |
3.1 years | 3.6 years | ||||||
Expected volatility |
103 | % | 86 | % | ||||
Risk-free interest rate |
0.81 | % | 1.02 | % | ||||
Fair market value (in thousands) |
$ | 48 | $ | 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 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 six-month period ended June 30, 2011:
Weighted | |||||||||||||||
Average | |||||||||||||||
Weighted | Remaining | ||||||||||||||
Average | Contractual | Aggregate | |||||||||||||
Shares | Exercise Price | Life | Intrinsic Value | ||||||||||||
(In thousands) | (Years) | (In thousands) | |||||||||||||
Options outstanding at December 31, 2010 |
326 | $ | 28.49 | 8.63 | |||||||||||
Granted |
| ||||||||||||||
Exercised |
| ||||||||||||||
Forfeited and expired |
(19 | ) | $ | 17.38 | |||||||||||
Options outstanding at June 30, 2011 |
307 | $ | 29.15 | 8.08 | $ | ||||||||||
Options exercisable at June 30, 2011 |
134 | $ | 42.34 | 7.17 | |||||||||||
Options vested or expected to vest at June 30, 2011 |
191 | $ | 34.86 | 7.67 |
During the six months ended June 30, 2011, 4,000 options expired. As of
June 30, 2011, there was approximately $708,000 of unrecognized compensation cost related to
stock option awards that is expected to be recognized as expense over a weighted average
period of 2.4 years.
No stock options were granted during the six month periods ended June 30, 2011 and 2010.
Restricted Stock
The Company recorded expense of approximately $25,000 and $50,000 during the three month
periods ended June 30, 2011 and June 30, 2010, respectively, related to restricted stock
awards granted in June 2007. The Company recorded expense of approximately $19,000 and $60,000
during the six month periods ended June 30, 2011 and June 30, 2010, respectively. The
restricted stock awards were valued based on the closing price of the Companys common stock
on their respective grant dates. Compensation expense has been recognized on a straight-line
basis over the 4 year vesting period of the awards.
Employee Stock Purchase Plan (2009 ESPP)
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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 June 30, 2011 and 2010 of
approximately $1,000 and $1,000, respectively. The Company recorded expense relating to the
2009 ESPP for the six month periods ended June 30, 2011 and 2010 of approximately $1,000 and
$3,000, respectively. Pursuant to the 2009 ESPP 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 June 30, 2011 and 2010, of $0 and $100,000, respectively for these shares. The Company
recorded expense of approximately $35,000 and $200,000 during the six month periods ended June
30, 2011 and June 30, 2010, respectively.
5. Agreements
In July 2010, the Company entered into an at the market equity offering sales agreement
with 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 has paid 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. For the three month period ended June 30, 2010,
for which the Company reported net income, all of the Companys common stock equivalents,
except for the Series D warrants, have been excluded from the diluted net income per share
calculation due to the exercise price of those common stock equivalents exceeding the fair
market value of the Companys common stock as of the date of the calculation. Although the
exercise price of the Series D warrants was $0.001 per share, the period for determining the
number of shares of common stock underlying the Series D warrants did not begin until July 1,
2010 and therefore no shares associated with the Series D warrants were included in the
diluted net income per share calculation. Accordingly, common stock equivalents of
approximately 460,000 and 1,533,000 at June 30, 2011 and 2010, respectively, were excluded
from the calculation of weighted average shares for diluted net loss per share.
7. Subsequent Event
From July 1, 2011 through August 5, 2011, the Company sold approximately 2,665,000 shares
of common stock pursuant to the ATM sales agreement resulting in net proceeds to the Company
of approximately $6,032,000. The Company did not have any other material recognizable or
unrecognizable subsequent events that occurred after June 30, 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 June 30, 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.
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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.
In February 2011, our board of directors voted unanimously to implement a 1:20 reverse stock split
of our 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
amounts discussed in this Form 10-Q have been adjusted to reflect the effect of this reverse split.
We expect cash on hand as of June 30, 2011, plus the proceeds of our at-the-market equity offering
sales agreement with McNicoll, Lewis & Vlak LLC, or MLV, received through August 5, 2011 to fund
our operations through the end of fiscal 2012. 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 fiscal 2012, we would be forced to cease all of our clinical and
other activities. 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. As a result of this uncertainty and the substantial doubt
about our ability to continue as a going concern as of December 31, 2010, 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. If we are unable to access additional funds in the future, it is likely that
our 2011 Report of Independent Registered Public Accounting Firm will also include a going concern
explanatory paragraph.
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. We have recently completed a Phase 2/3
clinical trial of ZYBRESTAT in patients with anaplastic thyroid cancer (ATC) and have ongoing
clinical trials of ZYBRESTAT in patients with 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.
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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
2010 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.
Julie Sosa, M.D., Associate Professor of Surgery and of Medicine at Yale University and primary
investigator in the Phase 2/3 study, presented final data from the trial at the American Society of
Clinical Oncology (ASCO) conference in Chicago, Illinois in June 2011. Dr. Sosa presented data
reflecting a median overall survival (OS) time of 5.2 months for patients who received ZYBRESTAT
and chemotherapy compared with 4.0 months for patients receiving chemotherapy alone, representing a
28% reduction in the risk of death for patients receiving ZYBRESTAT and chemotherapy. For patients
treated with ZYBRESTAT and chemotherapy, the data suggested that the likelihood of being alive at
six months was 48% compared with 35% for patients treated with the control arm regimen. At one
year, the data suggested that the likelihood of being alive was 26% for patients treated with
ZYBRESTAT and chemotherapy compared with 9% for patients treated with chemotherapy alone. As in
other studies, ZYBRESTAT appeared to be well tolerated.
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 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.
Edward Garon, M.D., Assistant Professor of Medicine at the University of California, Los Angeles
and primary investigator in the study, presented the overall survival data from this study at the
ASCO conference in Chicago, Illinois in June 2011. Dr. Garons updated analysis, conducted
approximately 11 months after the enrollment of the last patient in June 2010, showed that the
combination regimen of ZYBRESTAT plus bevacizumab, carboplatin and paclitaxel (ZYBRESTAT arm)
appeared to be well-tolerated with no significant cumulative toxicities when compared with the
control arm of the study. In addition, a pre-specified subgroup analysis showed meaningful
improvements in median time to progression for patients with poor performance status (ECOG
Performance Status 1). Poor performance status in this context refers to patients who have
additional medical complications, suffer from additional illnesses such as emphysema or diabetes,
or who may be taking other medications. While the median time to progression for the overall
patient
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population was similar in both arms of the study, 8.6 months for the ZYBRESTAT arm compared
with 9.0 months on the control arm, an analysis of the patient strata showed that patients with
poor performance status who received ZYBRESTAT in addition to bevacizumab and chemotherapy achieved
a median time to progression of 9.8 months compared with only 3.8 months for patients in this
same subgroup on the control arm of the study with a hazard ratio of 0.51. This data, suggesting
that the addition of ZYBRESTAT may benefit patients with a poorer performance status, is
preliminary at this stage. However, several attendees at the conference shared our view that more
study is warranted by the meaningful improvements suggested among patients with poor performance
status.
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.
Investigators initiated 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.
The June 2011 ASCO meeting in Chicago, Illinois included an announcement that the addition of
Avastin (bevacizumab) to a chemotherapy regimen reduces the risk of progression in patients with
platinum-sensitive ovarian cancer. This is of particular interest to OXiGENE in view of the NCI /
CTEP Phase 2 study of ZYBRESTAT in combination with bevacizumab for platinum-sensitive ovarian
cancer patients, and we are encouraged to see additional data from other studies supporting use of
bevacizumab in platinum-sensitive ovarian cancer patients.
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.
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.
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 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,
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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
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. We have completed the final analysis of this study and look forward to either
publishing the data or presenting it at an upcoming medical meeting.
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 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 for 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
to:
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.
Findings from the Phase 2 study, including effects on retinal thickness and retinal bleeding, are
expected to be presented at a future ophthalmology meeting.
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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 June 30, 2011 and 2010
Revenue
We reported no licensing revenue for the three months ended June 30, 2011 and 2010. Our
only current source of potential 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, if any, 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 June 30, | ||||||||||||||||||||||||
2011 | 2010 | |||||||||||||||||||||||
% of Total | % of Total | |||||||||||||||||||||||
Operating | Operating | Increase (Decrease) | ||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | Amount | % | |||||||||||||||||||
Research and development |
$ | 1,499 | 52 | % | $ | 3,348 | 67 | % | $ | (1,849 | ) | -55 | % | |||||||||||
General and administrative |
1,401 | 48 | % | 1,678 | 33 | % | (277 | ) | -16 | % | ||||||||||||||
Total operating expenses |
$ | 2,900 | 100 | % | $ | 5,026 | 100 | % | $ | (2,126 | ) | -42 | % | |||||||||||
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 June 30, | ||||||||||||||||||||||||
2011 | 2010 | |||||||||||||||||||||||
% of Total | % of Total | Increase (Decrease) | ||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | Amount | % | |||||||||||||||||||
External services |
$ | 692 | 46 | % | $ | 2,405 | 72 | % | $ | (1,713 | ) | -71 | % | |||||||||||
Employee compensation and related |
556 | 37 | % | 770 | 23 | % | (214 | ) | -28 | % | ||||||||||||||
Employee stock-based compensation |
118 | 8 | % | 13 | 0 | % | 105 | 808 | % | |||||||||||||||
Other |
133 | 9 | % | 160 | 5 | % | (27 | ) | -17 | % | ||||||||||||||
Total research and development |
$ | 1,499 | 100 | % | $ | 3,348 | 100 | % | $ | (1,849 | ) | -55 | % | |||||||||||
The reduction in external services expenses for the quarter ended June 30, 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 $900,000. This reduction is primarily
attributable to lower costs of our ATC study for the comparable 2011 period resulting from our
decision to discontinue further recruitment of patients in this study in February 2010. In
addition, we experienced $700,000 in reductions in expenses on our OXi4503 and ZYBRESTAT for
Ophthalmology programs for the comparable 2011 period, primarily related to our decision in
February 2010 to scale back efforts on some of our projects in these areas as well.
The reduction in employee compensation and related expenses for the quarter ended June
30, 2011 compared to the same three month period of 2010 is due to a 29% 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 increase in stock-based compensation expense for the quarter ended June 30, 2011
compared to the same three month period of 2010 is primarily due to the timing of issuance and
vesting of stock options 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 June 30, | ||||||||||||||||||||||||
2011 | 2010 | |||||||||||||||||||||||
% of Total | % of Total | Increase (Decrease) | ||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | Amount | % | |||||||||||||||||||
Employee compensation and related |
$ | 497 | 36 | % | $ | 519 | 31 | % | $ | (22 | ) | -4 | % | |||||||||||
Employee stock-based compensation |
211 | 15 | % | 169 | 10 | % | 42 | 25 | % | |||||||||||||||
Consulting and professional services |
408 | 29 | % | 683 | 41 | % | (275 | ) | -40 | % | ||||||||||||||
Other |
285 | 20 | % | 307 | 18 | % | (22 | ) | -7 | % | ||||||||||||||
Total general and administrative |
$ | 1,401 | 100 | % | $ | 1,678 | 100 | % | $ | (277 | ) | -16 | % | |||||||||||
The reduction in consulting and professional services expenses for the quarter ended
June 30, 2011 compared to the same three month period of 2010 is primarily due to lower board
member compensation attributable to lower stock cost during the 2011 quarter as board members
are paid in the form of non-cash stock grants. In addition, we experienced lower legal,
accounting and service provider expenses due to fewer significant transactions during the 2011
quarter.
Other Income and Expenses
The table below summarizes Other Income and Expense in our Statements of Operations for
the three month periods ended June 30, 2011 and 2010, in thousands:
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Three months ended June 30, | Increase (Decrease) | |||||||||||||||
2011 | 2010 | Amount | % | |||||||||||||
Change in fair value of warrants and other
financial instruments |
$ | (31 | ) | $ | 7,539 | $ | (7,570 | ) | -100 | % | ||||||
Investment income |
1 | 4 | (3 | ) | -75 | % | ||||||||||
Other income (expense), net |
(2 | ) | 20 | (22 | ) | -110 | % | |||||||||
Total |
$ | (32 | ) | $ | 7,563 | $ | (7,595 | ) | -100 | % | ||||||
We recorded an unrealized (non cash) loss in 2011 and gain 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 June 30, 2011 and 2010, in
thousands.
Three months ended June 30, | ||||||||
2011 | 2010 | |||||||
Committed Equity Financing Facility Warrants |
$ | | $ | 88 | ||||
Direct Registration Warrants |
(31 | ) | 1,753 | |||||
Private Placement Warrants |
| 5,698 | ||||||
Total (loss) gain on change in fair market value of
derivatives |
$ | (31 | ) | $ | 7,539 | |||
Six Months Ended June 30, 2011 and 2010
Revenue
We reported no licensing revenue for the six months ended June 30, 2011 and 2010. Our only
current source of potential 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, if any, are expected to be minimal. We do not expect to generate material revenue or
fee income unless we enter into a major licensing arrangement.
Costs and expenses
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:
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Six Months ended June 30, | ||||||||||||||||||||||||
2011 | 2010 | |||||||||||||||||||||||
% of Total | % of Total | |||||||||||||||||||||||
Operating | Operating | Increase (Decrease) | ||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | Amount | % | |||||||||||||||||||
Research and development |
$ | 3,182 | 53 | % | $ | 7,533 | 66 | % | $ | (4,351 | ) | -58 | % | |||||||||||
General and administrative |
2,786 | 47 | % | 3,381 | 30 | % | (595 | ) | -18 | % | ||||||||||||||
Restructuring |
| 0 | % | 510 | 4 | % | (510 | ) | -100 | % | ||||||||||||||
Total operating expenses |
$ | 5,968 | 100 | % | $ | 11,424 | 100 | % | $ | (5,456 | ) | -48 | % | |||||||||||
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:
Six Months ended June 30, | ||||||||||||||||||||||||
2011 | 2010 | |||||||||||||||||||||||
% of Total | % of Total | Increase (Decrease) | ||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | Amount | % | |||||||||||||||||||
External services |
$ | 1,550 | 49 | % | $ | 5,193 | 69 | % | $ | (3,643 | ) | -70 | % | |||||||||||
Employee compensation and related |
1,192 | 37 | % | 1,934 | 26 | % | (742 | ) | -38 | % | ||||||||||||||
Employee stock-based compensation |
166 | 5 | % | 47 | 0 | % | 119 | 253 | % | |||||||||||||||
Other |
274 | 9 | % | 359 | 5 | % | (85 | ) | -24 | % | ||||||||||||||
Total research and development |
$ | 3,182 | 100 | % | $ | 7,533 | 100 | % | $ | (4,351 | ) | -58 | % | |||||||||||
The reduction in external services expenses for the six month period ended June 30, 2011
compared to the same six month period in 2010 is primarily attributable to a reduction in spending
on our ZYBRESTAT for Oncology program of approximately $2,400,000. This reduction is primarily
attributable to lower costs of our ATC study for the comparable 2011 period resulting from our
decision to discontinue further recruitment of patients in this study in February 2010. In
addition, we experienced $1,100,000 in reductions in expenses on our OXi4503 and ZYBRESTAT for
Ophthalmology programs for the comparable 2011 period, primarily related to our decision in
February 2010 to scale back efforts on some of our projects in these areas as well.
The reduction in employee compensation and related expenses for the six months ended June 30,
2011 compared to the same six month period of 2010 is due to a 42% 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 increase in stock-based compensation expense for the six month period ended June 30, 2011
compared to the same six month period of 2010 is primarily due to the timing of issuance and
vesting of stock options for the comparable periods.
The reduction in other expenses for the six month period ended June 30, 2011 compared to the
same six 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:
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Table of Contents
Six Months ended June 30, | ||||||||||||||||||||||||
2011 | 2010 | |||||||||||||||||||||||
% of Total | % of Total | Increase (Decrease) | ||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | Amount | % | |||||||||||||||||||
Employee compensation and related |
$ | 985 | 35 | % | $ | 1,135 | 33 | % | $ | (150 | ) | -13 | % | |||||||||||
Employee stock-based compensation |
285 | 10 | % | 227 | 7 | % | $ | 58 | 26 | % | ||||||||||||||
Consulting and professional services |
966 | 35 | % | 1,455 | 43 | % | $ | (489 | ) | -34 | % | |||||||||||||
Other |
550 | 20 | % | 564 | 17 | % | $ | (14 | ) | -2 | % | |||||||||||||
Total general and administrative |
$ | 2,786 | 100 | % | $ | 3,381 | 100 | % | $ | (595 | ) | -18 | % | |||||||||||
The reduction in employee compensation and related expenses for the six month period
ended June 30, 2011 compared to the same six month period of 2010 is due to a reduction in our
average full time equivalents for the comparable periods of 16%. 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 six month period
ended June 30, 2011 compared to the same six month period of 2010 is primarily due to one time
costs incurred in our attempt to acquire Vaxgen Inc and due to the PIPE financing deal that
did not recur in the 2011 period and lower board member compensation attributable to lower
stock cost basis during the 2011 six month period as board members are paid in the form of
non-cash stock grants. In addition, we experienced lower legal, accounting and service
provider expenses due to fewer significant transactions during the 2011 period.
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, primarily associated with personnel-related termination costs in connection
with this restructuring. Key aspects of the restructuring and its effects on our current
clinical trials were as follows:
| We continue to advance our Phase 2 ZYBRESTAT trial in non-small cell lung cancer (FALCON study), with updated safety and efficacy results presented at the 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 on the study. | ||
| We discontinued enrolling patients in our OXi4503 Phase 1b trial in patients with hepatic tumors. | ||
| 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 data 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
six month periods ended June 30, 2011 and 2010, in thousands:
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Six months ended June 30, | Increase (Decrease) | |||||||||||||||
2011 | 2010 | Amount | % | |||||||||||||
Change in fair value of warrants and other financial instruments |
$ | 2,179 | $ | 2,906 | $ | (727 | ) | -25 | % | |||||||
Investment income |
2 | 11 | (9 | ) | -82 | % | ||||||||||
Other income (expense), net |
(8 | ) | 16 | (24 | ) | -150 | % | |||||||||
Total |
$ | 2,173 | $ | 2,933 | $ | (760 | ) | -26 | % | |||||||
We recorded an unrealized (non cash) gain in both the 2011 and 2010 periods as a result
of the change in the estimated Fair Market Value (FMV) of our common stock warrants issued in
connection with the offerings 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 for the six
month periods ended June 30, 2011 and 2010, in thousands.
Six months ended June 30, | ||||||||
2011 | 2010 | |||||||
Committed Equity Financing Facility Warrants |
$ | 3 | $ | 90 | ||||
Direct Registration Warrants |
59 | 1,978 | ||||||
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 | 5,271 | ||||||
Total gain on change in fair market value of derivatives |
$ | 2,179 | $ | 2,906 | ||||
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 June 30, 2011, we had an accumulated deficit of
approximately $211,495,000. We expect to continue to incur ongoing 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 $8,500,000 at June 30, 2011. From July 1, 2011 through August 5, 2011,
additional net proceeds were received under the July 2011 prospectus supplement of
approximately $6,032,000.
The following table summarizes our cash flow activities for the periods indicated, in
thousands:
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Six months ended June 30, | ||||||||
2011 | 2010 | |||||||
Operating activities: |
||||||||
Net loss |
$ | (3,795 | ) | $ | (8,491 | ) | ||
Non-cash adjustments to net loss |
(1,612 | ) | (2,328 | ) | ||||
Changes in operating assets and liabilities |
(1,131 | ) | (2,589 | ) | ||||
Net cash used in operating activities |
(6,538 | ) | (13,408 | ) | ||||
Investing activities: |
||||||||
Change in other assets |
| 38 | ||||||
Net cash provided by investing activities |
| 38 | ||||||
Financing activities: |
||||||||
Proceeds from issuance of common stock |
10,396 | 6,675 | ||||||
Net cash provided by financing activities |
10,396 | 6,675 | ||||||
Increase (decrease) in cash and cash equivalents |
3,858 | (6,695 | ) | |||||
Cash and cash equivalents at beginning of period |
4,602 | 13,932 | ||||||
Cash and cash equivalents at end of period |
$ | 8,460 | $ | 7,237 | ||||
Non-cash adjustments to net loss in the six month period ended June 30, 2011
consist primarily of a gain from a change in the fair value of warrants and other financial
instruments of $2,179,000, offset in part by stock compensation expense of $486,000 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 $1,015,000 and an increase in prepaid expenses and other current assets of
$151,000. Net cash provided by financing activities for the six month period ended June 30,
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 was 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.
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.
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.
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During the six months ended June 30, 2011, we sold approximately 4,623,000 shares of common
stock pursuant to the sales agreement resulting in net proceeds to us of approximately
$10,396,000. From July 1, 2011 through August 5, 2011, we sold approximately 2,665,000 shares of
common stock pursuant to the ATM sales agreement resulting in net proceeds to the Company of
approximately $6,032,000. Under our current prospectus supplement to Form S-3 dated July 8,
2011, there remains approximately $751,000 in net proceeds available to be sold under the ATM
arrangement. 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.
Based on our current ongoing programs and operations, we will need to access additional
funds to remain a going concern beyond fiscal 2012. Including net proceeds from the sale of
shares through August 5, 2011 under the ATM sales agreement described above, we expect that our
financial resources will be sufficient to fund our operations through fiscal 2012. 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, will likely 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. As a result of this uncertainty and the substantial doubt
about our ability to continue as a going concern as of December 31, 2010, 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. If we are unable to access additional funds in the future, it is likely
that our 2011 Report of Independent Registered Public Accounting Firm will also include a going
concern explanatory paragraph.
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. We anticipate a continued reduction in our cash utilization over the next several
quarters resulting from the conclusion of a number of our clinical projects in 2011 and based on
those future projects to which we are currently committed. We continue to evaluate our future
potential product development options and our cash utilization may vary depending on conclusions
made regarding those options.
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.
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Item 3. Quantitative and Qualitative Disclosures About Market Risk
At June 30, 2011, we did not hold any derivative financial instruments. As of June 30,
2011 we did 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 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 as of
June 30, 2011 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
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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 as of June 30, 2011, plus the proceeds of our at-the-market equity
offering sales agreement with McNicoll, Lewis & Vlak LLC, or MLV, received through August 5, 2011,
to fund our operations through the end of fiscal 2012. In order to remain a going concern beyond
the end of fiscal 2012, 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 fiscal 2012, we would be forced to cease all of our clinical and other
activities.
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 As a result of this uncertainty and the
substantial doubt about our ability to continue as a going concern as of December 31, 2010, 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. If we are unable to access additional funds
in the future, it is likely that our 2011 Report of Independent Registered Public Accounting Firm
will also include 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 timely achieve compliance with NASDAQs independent director and
audit committee requirements. 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.
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 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
requirements for continued listing. 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
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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
31.1 Certification of Principal Executive Officer required by Section 302 of the
Sarbanes-Oxley Act of 2002.
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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.
101 The following materials from OXiGENE, Inc.s Quarterly Report on Form 10-Q for the
quarter ended June 30, 2011, formatted in XBRL (eXtensible Business Reporting Language): (i)
Condensed Balance Sheets at June 30, 2011 and December 31, 2010, (ii) Condensed Statements of
Operations for the three and six months ended June 30, 2011 and 2010, (iii) Condensed Statements
of Cash Flows for the six months ended June 30, 2011 and 2010, and (iv) Notes to Condensed
Financial Statements.**
**Pursuant to Rule 406T of Regulation S-T, the Interactive Data Files on Exhibit 101 hereto
are deemed not filed or part of a registration statement or prospectus for purposes of Sections
11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Section
18 of the Securities and Exchange Act of 1934, as amended, and otherwise are not subject to
liability under those sections.
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: August 12, 2011 | By: | /s/ Peter J. Langecker | ||
Peter J. Langecker | ||||
Chief Executive Officer |
Date: August 12, 2011 | By: | /s/ James B. Murphy | ||
James B. Murphy | ||||
Vice President and Chief Financial Officer | ||||
EXHIBIT INDEX
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.
101 The following materials from OXiGENE, Inc.s Quarterly Report on Form 10-Q for the
quarter ended June 30, 2011, formatted in XBRL (eXtensible Business Reporting Language): (i)
Condensed Balance Sheets at June 30, 2011 and December 31, 2010, (ii) Condensed Statements of
Operations for the three and six months ended June 30, 2011 and 2010, (iii) Condensed Statements
of Cash Flows for the six months ended June 30, 2011 and 2010, and (iv) Notes to Condensed
Financial Statements.**
**Pursuant to Rule 406T of Regulation S-T, the Interactive Data Files on Exhibit 101 hereto
are deemed not filed or part of a registration statement or prospectus for purposes of Sections
11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Section
18 of the Securities and Exchange Act of 1934, as amended, and otherwise are not subject to
liability under those sections.
33