Oncotelic Therapeutics, Inc. - Quarter Report: 2011 September (Form 10-Q)
Table of Contents
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 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
November 4, 2011, there were 14,879,857 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)
(Unaudited)
September 30, 2011 | December 31, 2010 | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 12,644 | $ | 4,602 | ||||
Restricted cash |
20 | 75 | ||||||
Prepaid expenses |
195 | 256 | ||||||
Other current assets |
74 | 75 | ||||||
Total current assets |
12,933 | 5,008 | ||||||
Furniture and fixtures, equipment and leasehold improvements |
836 | 1,512 | ||||||
Accumulated depreciation |
(793 | ) | (1,425 | ) | ||||
43 | 87 | |||||||
License agreements, net of accumulated amortization
of $1,187 and $1,114 at September 30, 2011 and December
31, 2010, respectively |
313 | 386 | ||||||
Other assets |
86 | 86 | ||||||
Total assets |
$ | 13,375 | $ | 5,567 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT) |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 473 | $ | 458 | ||||
Accrued research and development |
1,171 | 2,125 | ||||||
Accrued restructuring |
1,113 | | ||||||
Accrued other |
212 | 628 | ||||||
Total current liabilities |
2,969 | 3,211 | ||||||
Derivative liability long term |
9 | 7,611 | ||||||
Total liabilities |
2,978 | 10,822 | ||||||
Commitments and contingencies |
||||||||
Stockholders equity (deficit) |
||||||||
Preferred Stock, $.01 par value, 15,000 shares
authorized; 0 shares issued and outstanding at September
30, 2011 and December 31, 2010 |
| | ||||||
Common stock, $.01 par value, 300,000 shares
authorized and 14,771 shares issued and outstanding at
September 30, 2011; 300,000 shares authorized and 5,501
shares issued and outstanding at December 31, 2010 |
148 | 55 | ||||||
Additional paid-in capital |
225,257 | 202,390 | ||||||
Accumulated deficit |
(215,008 | ) | (207,700 | ) | ||||
Total stockholders equity (deficit) |
10,397 | (5,255 | ) | |||||
Total liabilities and stockholders equity (deficit) |
$ | 13,375 | $ | 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 September 30, | Nine months ended September 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Operating costs and expenses(1) : |
||||||||||||||||
Research and development |
$ | 1,098 | $ | 2,379 | $ | 4,280 | $ | 9,912 | ||||||||
General and administrative |
1,309 | 1,256 | 4,095 | 4,637 | ||||||||||||
Restructuring |
1,146 | | 1,146 | 510 | ||||||||||||
Total operating costs and expenses |
3,553 | 3,635 | 9,521 | 15,059 | ||||||||||||
Loss from operations |
(3,553 | ) | (3,635 | ) | (9,521 | ) | (15,059 | ) | ||||||||
Change in fair value of warrants and other
financial instruments |
40 | (9,893 | ) | 2,219 | (6,987 | ) | ||||||||||
Investment income |
1 | 3 | 3 | 14 | ||||||||||||
Other (expense) income, net |
(1 | ) | (11 | ) | (9 | ) | 5 | |||||||||
Net loss |
$ | (3,513 | ) | $ | (13,536 | ) | $ | (7,308 | ) | $ | (22,027 | ) | ||||
Basic and diluted net loss per share |
$ | (0.25 | ) | $ | (3.47 | ) | $ | (0.74 | ) | $ | (6.24 | ) | ||||
Weighted-average number of common shares
outstanding Basic and diluted |
13,969 | 3,896 | 9,870 | 3,530 | ||||||||||||
|
||||||||||||||||
(1) Includes share based compensation expense as
follows: |
||||||||||||||||
Research and development |
$ | 5 | $ | 62 | $ | 171 | $ | 109 | ||||||||
General and administrative |
59 | 114 | $ | 379 | $ | 541 | ||||||||||
Total share based compensation expense |
$ | 64 | $ | 176 | $ | 550 | $ | 650 | ||||||||
See accompanying notes.
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OXiGENE, Inc.
Condensed Statements of Cash Flows
(All amounts in thousands)
(Unaudited)
(All amounts in thousands)
(Unaudited)
Nine months ended September 30, | ||||||||
2011 | 2010 | |||||||
Operating activities: |
||||||||
Net loss |
$ | (7,308 | ) | $ | (22,027 | ) | ||
Adjustments to reconcile net loss to net cash used in operating
activities: |
||||||||
Change in fair value of warrants and other financial instruments |
(2,219 | ) | 6,987 | |||||
Depreciation |
44 | 77 | ||||||
Amortization of license agreement |
73 | 73 | ||||||
Stock-based compensation |
550 | 650 | ||||||
Changes in operating assets and liabilities: |
||||||||
Restricted cash |
55 | 65 | ||||||
Prepaid expenses and other current assets |
62 | 232 | ||||||
Accounts payable, accrued expenses and other payables |
(234 | ) | (4,000 | ) | ||||
Net cash used in operating activities |
(8,977 | ) | (17,943 | ) | ||||
Investing activities: |
||||||||
Changes in other assets |
| 40 | ||||||
Net cash provided by investing activities |
| 40 | ||||||
Financing activities: |
||||||||
Proceeds from issuance of common stock, net of acquisition costs |
17,019 | 10,380 | ||||||
Proceeds from exercise of employee stock plans |
| 45 | ||||||
Net cash provided by financing activities |
17,019 | 10,425 | ||||||
Increase (decrease) in cash and cash equivalents |
8,042 | (7,478 | ) | |||||
Cash and cash equivalents at beginning of period |
4,602 | 13,932 | ||||||
Cash and cash equivalents at end of period |
$ | 12,644 | $ | 6,454 | ||||
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 | ||||
Fair market value of warrants at exercise |
$ | | $ | 5,043 |
See accompanying notes.
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OXiGENE, Inc.
Notes to Condensed
Financial Statements
September 30, 2011
(Unaudited)
September 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 nine months ended
September 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.
During the nine months ended September 30, 2011, the Company sold approximately 7,707,000
shares of common stock pursuant to an at the market (ATM) equity offering sales agreement
with McNicoll, Lewis & Vlak LLC, or MLV, resulting in net proceeds to the Company of
approximately $17,019,000. In October 2011 the Company sold approximately 86,000 shares of
common stock pursuant to the ATM sales agreement resulting in net proceeds to the Company of
approximately $128,000. There remains a total of approximately $3,700 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.
On September 1, 2011, the Company announced a restructuring plan designed to focus the
Companys capital resources on its most promising early-stage clinical programs and further
reduce its cash utilization. The Company announced the following key aspects of the
restructuring and their effects on the Companys operations including current and planned
clinical trials:
| At this time, a Company sponsored Phase 3 registrational study of ZYBRESTAT in patients with anaplastic thyroid cancer (ATC) funded entirely by Company financial resources is not feasible. OXiGENE intends to continue to explore options for conducting such a study, including potential collaborations with national and international head and neck cancer cooperative groups. Future development decisions concerning ZYBRESTAT in patients with ATC will be made following a review of all options by OXiGENEs management and its board of directors. | ||
| OXiGENE is concluding the final analysis of its completed Phase 2 study of ZYBRESTAT in conjunction with standard chemotherapy and bevacizumab in patients with non-small cell lung cancer (FALCON study). Once the final overall survival data is available a decision regarding further development of the study of ZYBRESTAT in patients with NSCLC will be made. Any future development decisions concerning the study of ZYBRESTAT in patients with NSCLC will be made following review of final data by the Companys management and board of directors. | ||
| OXiGENE plans to continue to support the ongoing randomized Phase 2 trial of ZYBRESTAT in combination with bevacizumab in patients with relapsed ovarian cancer, which is an NCI-sponsored study being conducted by the Gynecologic Oncology Group (GOG), an organization dedicated to clinical research in the field of gynecologic cancer. | ||
| OXiGENE plans to continue support of the ongoing investigator-sponsored Phase 1 trial of OXi4503 in patients with AML or myelodysplastic syndrome (MDS), being conducted at the University of Florida and with support by The Leukemia & Lymphoma Societys Therapy Acceleration Program. | ||
| OXiGENE will evaluate additional early-stage development opportunities for its two product candidates, ZYBRESTAT and OXi4503, subject to available resources at the time. | ||
| The Company is reducing its workforce by 11 full-time equivalent employees or approximately 61%. |
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| The Company will seek to reduce the amount of space it currently rents, primarily by closing its office in Waltham, Massachusetts and by conducting its operations only out of its South San Francisco office as soon as practicable. |
The Company offered severance benefits to the terminated employees, and anticipates
recording a total charge of approximately $1,200,000, primarily associated with personnel-related
termination costs. In order to provide for an orderly transition, the Company is implementing the
reduction in work force in a phased manner. The Company took a restructuring charge in the third
quarter of 2011 of approximately $1,146,000, with the remainder expected to be taken over the
following two quarters as the transition is effected. Substantially all of the charge is
expected to represent cash expenditures. The Company anticipates that, with its current financial
resources, it will be able to support the completion of the ongoing clinical studies outlined
above. Should the Company decide to initiate additional studies, it would need to raise
additional capital. Upon completion of the restructuring activities outlined above, the Company
expects to reduce expenses from its current levels by an annual amount of approximately
$2,000,000.
Based on the Companys current ongoing programs and operations and taking into
consideration the expected reductions in cash utilization resulting from its September 2011
reduction in force, the Companys expect its current cash resources will be sufficient to fund
operations through the first half of fiscal 2013. 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
future or reduce cash expenditures as anticipated, 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 September 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
September 30, 2011 and December 31, 2010, OXiGENE held $12,664,000 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
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any knowledge that the services will be performed other than ratably. Costs incurred under
contracts with clinical trial sites and principal investigators are generally accrued on a
patient-treated basis consistent with the terms outlined in the contract. In determining costs
incurred on some of these programs, the Company takes into consideration a number of factors,
including estimates and input provided by internal program managers. Upon termination of such
contracts, the Company is normally only liable for costs incurred and committed to date. As a
result, accrued research and development expenses represent the Companys reasonably estimated
contractual liability to outside service providers at any particular point in time.
Accounting for Derivative Financial Instruments Indexed to and Potentially Settled in the
Companys Common stock
The Company evaluates all derivative financial instruments issued in connection with
its equity offerings when determining the proper accounting treatment for such
instruments in the Companys financial statements. The Company considers a number of
generally accepted accounting principles to determine such treatment. The Company
performs a number of steps to evaluate the features of the instrument against the
guidance provided in the accounting pronouncements in order to determine the appropriate
accounting treatment. The Companys policy with regard to settling outstanding financial
instruments is to settle those with the earliest maturity date first which essentially
sets the order of preference for settling the awards. In the majority of circumstances,
the Company utilizes the Black Scholes method to determine the fair value of its
derivative financial instruments. In some cases, where appropriate, the Company utilizes
the Binomial method or other appropriate methods to determine the fair value of such
derivative financial instruments. Key valuation factors in determining the fair value
include, but are not limited to, the current stock price as of the date of measurement,
the exercise price, the remaining contractual life, expected volatility for the
instrument and the risk-free interest rate. Changes in fair value are recorded as a gain
or loss in the Companys Statement of Operations with the corresponding amount recorded
as an adjustment to liability on its Balance Sheet. The expected volatility factor, in
particular, is subject to significant variability from measurement period to measurement
period and can result in large gains or losses from period to period.
Patents and Patent Applications
The Company has filed applications for patents in connection with technologies that it is
developing. The patent applications and any patents issued as a result of these applications
are important to the protection of the Companys technologies that may result from its
research and development efforts. Costs associated with patent applications and maintaining
patents are expensed as general and administrative expense as incurred.
Stock-based Compensation
The Company expenses the estimated fair value of all share-based payments issued to
employees over the vesting period. The Company has a 2005 Stock Plan (2005 Plan) 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
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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:
September 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 |
(793 | ) | (1,425 | ) | ||||
Total property and equipment |
$ | 43 | $ | 87 | ||||
3. Restructuring |
On September 1, 2011, the Company announced a restructuring plan designed to focus the
Companys capital resources on its most promising early-stage clinical programs and further
reduce its cash utilization. In connection with this restructuring, the Company recognized
approximately $721,000 of research and development restructuring expenses and approximately
$425,000 of general and administrative restructuring expenses in the quarter ended September 30,
2011. The restructuring expenses include severance payments, health and medical benefits and
related taxes, which are expected to be paid through the end of fiscal 2012.
The following table sets forth the components of the Companys restructuring for the
three-month period ended September 30, 2011 (in thousands):
Amounts Paid Through | Amounts Accrued as of | |||||||||||
Charges | September 30, 2011 | September 30, 2011 | ||||||||||
General and
Administrative
Employee severance
and related costs |
$ | 425 | $ | (21 | ) | $ | 404 | |||||
Research and
Development
Employee severance
and related costs |
721 | (12 | ) | 709 | ||||||||
Total restructuring |
$ | 1,146 | $ | (33 | ) | $ | 1,113 | |||||
4. License agreements |
In August 1999, the Company entered into an exclusive license agreement for the
commercial development, use and sale of products or services covered by certain patent rights
owned by Arizona State University. From the inception of the agreement through September 30,
2011, the Company has paid a total of $2,500,000 in connection with this license. The Company
capitalized the net present value of the total amount paid under the initial terms of the
license, or $1,500,000, and is amortizing this amount over the patent life or 15.5 years.
The Company expects to record amortization expense related to this license agreement of
approximately $8,100 per month through November 2014. The net book value at September 30, 2011
and December 31, 2010, was approximately $313,000 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
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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.
5. Stockholders Equity (Deficit), Common and Preferred Shares
The Company had 300,000,000 shares of common stock authorized as of September 30, 2011
and December 31, 2010. As of September 30, 2011, the Company had approximately 14,771,000
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. 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.
During the nine months ended September 30, 2011, the Company sold approximately 7,707,000
shares of common stock pursuant to the ATM sales agreement resulting in net proceeds to the
Company of approximately $17,019,000. In October 2011 the Company sold approximately 86,000
shares of common stock pursuant to the ATM sales agreement resulting in net proceeds to the
Company of approximately $128,000. Under the Companys current prospectus supplement to Form
S-3 dated July 8, 2011, there remains approximately $3,700 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 nine 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 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 nine month period ended September 30, 2011:
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Shares Issued in Connection with: | Shares Issued | Net Proceeds | ||||||
(in thousands) | ||||||||
Director fees |
8 | $ | | |||||
ATM |
7,707 | 17,019 | ||||||
Private Placement Warrant Exchange |
1,554 | | ||||||
Other |
1 | | ||||||
Totals |
9,270 | $ | 17,019 | |||||
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
nine month period ended September 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 nine months ended September 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 |
(1,528 | ) | ||
Derivative liability outstanding at September 30, 2011 |
$ | 9 | ||
The table below summarizes the value of the warrant-related derivative liabilities recorded
on the Companys balance sheet (in thousands):
As of September 30, | As of December 31, | |||||||
2011 | 2010 | |||||||
Warrants Issued in Connection with: | Long-term | Long-term | ||||||
Committed Equity
Financing Facility |
$ | | $ | 6 | ||||
Direct Registration
Series I Warrants |
9 | 107 | ||||||
Private Placement Series
A Warrants |
| 4,143 | ||||||
Private Placement Series
C Warrants |
| 3,355 | ||||||
Total derivative liability |
$ | 9 | $ | 7,611 | ||||
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The gain (loss) from the change in fair value of warrants and other financial instruments
for the three and nine month periods ended September 30, 2011 and September 30, 2010 is
summarized below (in thousands):
Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Committed Equity Financing Facility Warrants |
$ | | $ | 5 | $ | 3 | $ | 95 | ||||||||
Direct Registration Warrants |
40 | 99 | 99 | 2,077 | ||||||||||||
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 |
| (9,997 | ) | 1,427 | (4,726 | ) | ||||||||||
Total gain (loss) on change in fair market
value of derivatives |
$ | 40 | $ | (9,893 | ) | $ | 2,219 | $ | (6,987 | ) | ||||||
The following is a summary of the Companys outstanding common stock warrants as of September
30, 2011 and December 31, 2010:
Number of Warrants outstanding as of: | ||||||||||||||||
(in thousands) | ||||||||||||||||
Weighted Average | ||||||||||||||||
Warrants Issued in Connection with: | Date of Issue | Exercise Price | September 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.
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;
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(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 September 30, 2011.
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 nine month period ended September 30, 2011. The Company
established the fair value of the Series A and C warrants using the Black-Scholes option valuation
model:
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Warrant Valuation on date | ||||||||||||
of Warrant Exchange | ||||||||||||
January 19, 2011 | Total Fair Market | |||||||||||
Series A | Series C | 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 Market | |||||||||||
Series A | Series C | 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. Effective October 14, 2011, the CEFF was terminated by the Company pursuant to the terms
of the common stock purchase agreement with Kingsbridge.
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 ending May 15,
2012. While the CEFF was effective, OXiGENE was able to draw down in tranches at discounts as
described in detail in the common stock purchase agreement. 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 September 30, 2011, there were a total of 253,671 shares available for sale
under the CEFF, which has since been terminated.
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
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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:
Series I Warrant Valuation as of: | ||||||||
September 30, 2011 | December 31, 2010 | |||||||
Series I | Series I | |||||||
Stock Price |
$ | 1.01 | $ | 4.60 | ||||
Exercise Price |
$ | 42.00 | $ | 42.00 | ||||
Contractual life (in Years) |
2.8 years | 3.6 years | ||||||
Expected volatility |
108 | % | 86 | % | ||||
Risk-free interest rate |
0.42 | % | 1.02 | % | ||||
Fair market value (in thousands) |
$ | 9 | $ | 107 | ||||
Options
The Companys 2005 Stock Plan as amended at the 2011 Annual Meeting of Stockholders in
October 2011 (the 2005 Plan) provides for the award of options, restricted stock and stock
appreciation rights to acquire up to 2,500,000 shares of the Companys common stock in the
aggregate. This number includes shares of its common stock, if any, that were subject to
awards under the Companys 1996 Stock Incentive Plan (the 1996 Plan) as of the date of
adoption of the 2005 Plan but which were returned or will be returned to the 2005 Plan upon
the cancellation, surrender or termination of such award. Currently, the 2005
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Plan allows for
awards of up to 200,000 shares that may be granted to any one 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 nine-month period ended September 30, 2011:
Weighted | ||||||||||||||||
Weighted | Average | |||||||||||||||
Average | Remaining | Aggregate | ||||||||||||||
Exercise | Contractual | Intrinsic | ||||||||||||||
Shares | Price | Life | Value | |||||||||||||
(In thousands) | (Years) | (In thousands) | ||||||||||||||
Options outstanding at December 31, 2010 |
326 | $ | 28.49 | |||||||||||||
Granted |
17 | $ | 1.14 | |||||||||||||
Exercised |
| |||||||||||||||
Forfeited and expired |
(78 | ) | $ | 19.98 | ||||||||||||
Options outstanding at September 30, 2011 |
265 | $ | 29.22 | 6.77 | ||||||||||||
Options exercisable at September 30, 2011 |
154 | $ | 35.63 | 5.51 | ||||||||||||
Options vested or expected to vest at
September 30, 2011 |
222 | $ | 31.09 | 6.42 |
During the nine months ended September 30, 2011, approximately 7,800 options expired. As
of September 30, 2011, there was approximately $449,000 of unrecognized compensation cost
related to stock option awards that is expected to be recognized as expense over a weighted
average period of 2.15 years.
A total of 17,000 stock options were granted during the nine month period ended September
30, 2011 and 257,000 stock options were granted during the nine month period ended September
30, 2010.
The following stock options were granted during the three and nine month periods ended
September 30, 2011 and September 30, 2010:
Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Options Granted (In
thousands) |
17 | 83 | 17 | 257 | ||||||||||||
Weighted average fair value |
$ | 0.79 | $ | 0.11 | $ | 0.79 | $ | 0.81 |
The fair values for the stock options granted were estimated at the date of grant using
the Black-Scholes option pricing model with the following weighted-average assumptions for the
three and nine month periods ended September 30, 2011 and 2010:
Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Weighted Average Assumptions
|
||||||||||||||||
Risk-free interest rate |
0.85 | % | 0.50 | % | 0.85 | % | 1.83 | % | ||||||||
Expected life |
5 years | 5 years | 5 years | 5 years | ||||||||||||
Expected volatility |
90 | % | 74 | % | 90 | % | 70 | % | ||||||||
Dividend yield |
0.00 | % | 0.00 | % | 0.00 | % | 0.00 | % |
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Restricted Stock
The Company recorded expense of $0 and approximately $11,000 during the three month
periods ended September 30, 2011 and September 30, 2010, respectively, related to restricted
stock awards granted in June 2007. The Company recorded expense of approximately $19,000 and
$71,000 during the nine month periods ended September 30, 2011 and September 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)
Under the 2009 Employee Stock Purchase Plan (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 September
30, 2011 and September 30, 2010 of approximately $0 and $3,000, respectively. The Company
recorded expense relating to the 2009 ESPP for the nine month periods ended September 30, 2011
and September 30, 2010 of approximately $1,000 and $6,000, 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 a 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 board of directors. In
September 2011, the board of directors approved an amendment and restatement of the policy
(the Amended and Restated Director Compensation Policy). The Amended and Restated Director
Compensation Policy provides for annual compensation of $80,000 in cash/equity value to each
non-employee director payable in two payments of $40,000 in cash/equity value, on January 2
and July 1. Each non-employee director may elect to receive such compensation in a
combination of fully vested options and/or stock and up to 50% in cash. Prior to the
September 2011 amendment, each of the Companys non-employee directors were granted 1,250
fully vested shares of common stock on both January 2 and July 1 of each year they were a
director. The Company recorded expense for the three month periods ended September 30, 2011
and September 30, 2010, of $13,000 and $29,000, respectively, for these shares. The Company
recorded expense of approximately $48,000 and $229,000 during the nine month periods ended
September 30, 2011 and September 30, 2010, respectively, for these shares.
6. 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.
7. 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 418,000 and 3,944,000 at September 30, 2011 and September 30, 2010,
respectively, were excluded from the calculation of weighted average shares for diluted net
loss per share.
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8. Subsequent Event
From October 1, 2011 through November 10, 2011, the Company sold approximately 86,000
shares of common stock pursuant to the ATM sales agreement resulting in net proceeds to the
Company of approximately $128,000. The Company did not have any other material
recognizable or unrecognizable subsequent events that occurred after September 30, 2011 up
through the date the Company issued these financial statements.
Effective October 14, 2011, the Company terminated the CEFF pursuant to the terms of the
common stock purchase agreement with Kingsbridge. The warrant for 12,500 shares of common
stock issued to Kingsbridge remains outstanding until August 19, 2013, subject to certain
conditions.
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Our Managements Discussion and Analysis of Financial Condition and Results of Operations
as of September 30, 2011 and September 30, 2010 should be read in conjunction with the
sections of our audited consolidated financial statements and notes thereto, as well as our
Managements Discussion and Analysis of Financial Condition and Results of Operations that
is included in our Annual Report on Form 10-K for the year ended December 31, 2010, and also
with the unaudited financial statements set forth in Part I, Item 1 of this Quarterly Report
on Form 10-Q.
Our Business
We are a clinical-stage, biopharmaceutical company developing novel therapeutics to treat
cancer and eye diseases. Our primary focus is the development of product candidates referred to
as vascular disrupting agents, or VDAs, that selectively disable and destroy abnormal blood
vessels that provide solid tumors a means of growth and survival and also are associated with
visual impairment in a number of ophthalmological diseases and conditions. To date, more than 400
subjects have been treated with ZYBRESTAT, our lead candidate, in human clinical trials, and the
drug candidate has generally been observed to be well-tolerated.
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.
On September 1, 2011, we announced a restructuring plan designed to focus our capital
resources on its most promising early-stage clinical programs and further reduce our cash
utilization. We announced the following key aspects of the restructuring and their effects on
our operations including current and planned clinical trials:
| At this time, a Company sponsored Phase 3 registrational study of ZYBRESTAT in patients with anaplastic thyroid cancer (ATC) funded entirely by our financial resources is not feasible. We intend to explore options for conducting such a study, including potential collaborations with national and international head and neck cancer cooperative groups. Future development decisions concerning ZYBRESTAT in patients with ATC will be made following a review of all options by our management and board of directors. | ||
| We are concluding the final analysis of our completed Phase 2 study of ZYBRESTAT in conjunction with standard chemotherapy and bevacizumab in patients with non-small cell lung cancer (FALCON study). Once the final overall survival data is available a decision regarding further development of the study of ZYBRESTAT in patients with NSCLC will be made. Any future development decisions concerning the study of ZYBRESTAT in patients with NSCLC will be made following review of final data by our management and board of directors. | ||
| We plan to continue the support of the ongoing randomized Phase 2 trial of ZYBRESTAT in combination with bevacizumab in patients with relapsed ovarian cancer, which is an NCI-sponsored study being conducted by the Gynecologic Oncology Group (GOG), an organization dedicated to clinical research in the field of gynecologic cancer. | ||
| We plan to continue support of the ongoing investigator-sponsored Phase 1 trial of OXi4503 in patients with AML or myelodysplastic syndrome (MDS), which is being conducted at the University of Florida and with support by The Leukemia & Lymphoma Societys Therapy Acceleration Program. | ||
| We will evaluate additional early-stage development opportunities for our two product candidates, ZYBRESTAT and OXi4503, subject to available resources at the time. | ||
| We are reducing our workforce by 11 full-time equivalent employees or approximately 61%. | ||
| We will seek to reduce the amount of space we currently rent primarily by closing our facility in Waltham, Massachusetts and by conducting our operations only out of our South San Francisco facility as soon as practicable. |
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We offered severance benefits to the terminated employees, and anticipate recording a
total charge of approximately $1,200,000, primarily associated with personnel-related termination
costs. In order to provide for an orderly transition, we are implementing the reduction in work
force in a phased manner. We took a restructuring charge in the third quarter of 2011 of
approximately $1,146,000, with the remainder expected to be taken over the following two quarters
as the transition is effected. Substantially all of the charge is expected to represent cash
expenditures. We anticipate that, with our current financial resources, we will be able to
support the completion of the ongoing clinical studies outlined above. Should we decide to
initiate additional studies, we would need to raise additional capital. Upon completion of the
restructuring activities outlined above, we expect to reduce expenses from our current levels by
an annual amount of approximately $2,000,000.
Based on our current ongoing programs and operations and taking into consideration the
expected reductions in cash utilization resulting from our September 2011 reduction in force, we
expect our current cash resources will be sufficient to fund operations through the first half of
fiscal 2013. 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. 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 round up and block the flow of blood to the tumor. The downstream tumor
environment is then deprived of oxygen and nutrients, 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 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.
The primary endpoint for the FACT trial was 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 prior to enrollment of patients.
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 many
of the patients screened for the study did not meet the trials inclusion criteria or 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.
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In June 2011, Julie Sosa, M.D., Associate Professor of Surgery and of Medicine at Yale
University and principal 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. 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.
In connection with the restructuring announced on September 1, 2011, we determined that a
Company sponsored Phase 3 registrational study of ZYBRESTAT in patients with anaplastic thyroid
cancer (ATC) funded entirely by our financial resources is not feasible. We continue to explore
options for conducting such a study, including potential collaborations with national and
international thyroid and head and neck cancer cooperative groups. Future development decisions
concerning ZYBRESTAT in patients with ATC will be made following a review of all options by our
management and board of directors.
ZYBRESTAT has been 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.
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 randomized, controlled Phase 2 clinical trial,
which we refer to as the FALCON trial, as a potential first-line treatment for stage IIIB/IV
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 angiogenesis, or to the control arm of the study, in which they receive a
standard combination regimen of carboplatin, paclitaxel and bevacizumab. The objective of the
study is to determine the safety, tolerability, and efficacy of ZYBRESTAT at a dose of 60
mg/m2 in combination with carboplatin, paclitaxel and bevacizumab in Stage IIIB or IV
non-squamous NSCLC.
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. In June 2010 the study reached its target enrollment with 63 patients randomized.
Primary endpoints of this study were safety of the combination therapy and progression-free
survival; secondary endpoints were overall survival and objective response rate.
Edward Garon, M.D., Assistant Professor of Medicine at the University of California, Los
Angeles and primary investigator in the study, presented the progression-free 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 present with higher tumor burden or larger tumors, who have additional medical
complications, who 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 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 chemotherapy and bevacizumab showed a progression-free survival of only 3.8
months as compared to a median time to progression of 9.8 months in this same subgroup when
receiving ZYBRESTAT along with chemotherapy and bevacizumab, 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 and we believe that more study is warranted by the
meaningful improvements suggested among patients with poor performance status.
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Dr. Garons presentation also included data on the achieved rate of objective response. In
terms of Partial Response as Best Overall Tumor Response (Intent to Treat) patients on the active
treatment arm including ZYBRESTAT achieved a 56% rate of objective response according to RECIST
criteria, as compared to 36% on the control arm.
Since the presentation of the progression-free survival data at ASCO 2011, the overall
survival follow-up has continued with each patient having been followed for survival for at least
one year following the initiation of study therapy. The final results from this analysis were
available in November 2011 and the analysis of the data showed that the combination regimen of
ZYBRESTAT plus bevacizumab, carboplatin and paclitaxel (ZYBRESTAT arm) was observed to be
well-tolerated with no significant cumulative toxicities or overlapping toxicities with
bevacizumab when compared with the control arm of the study (standard chemotherapy plus
bevacizumab). In addition, an analysis of patients with tumor burden greater than 10 cm suggested
meaningful improvements in overall survival for patients receiving ZYBRESTAT in addition to
bevacizumab and chemotherapy. For patients with this large tumor burden, median overall survival
was 14.2 months, compared with 11.0 months for patients on the control arm of the study. For the
overall patient population, no survival benefit was observed for patients receiving ZYBRESTAT.
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 are providing ZYBRESTAT to NCI for an NCI-sponsored study being 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 angiogenesis, 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.
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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, 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.
Currently, we are exploring possible clinical studies but we have no firm plans to continue
the evaluation of OXi4503 in patients with solid tumors. A proposal to study the use of OXi4503
in combination with a tyrosine kinase inhibitor in patients with advanced ovarian is in the
evaluation stage.
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 in 2012.
The general direction of future development of OXi4503 for hematologic indications will
depend on the outcome of the analysis of 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:
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| 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 to be presented at the 6th Asia-Pacific-Vitreo Retinal Society Congress
(APVRS) in Hyderabad, India on December 2, 2011.
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 September 30, 2011 and September 30, 2010
Revenue
We reported no licensing revenue for the three months ended September 30, 2011 and
September 30, 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 September 30, | ||||||||||||||||||||||||
2011 | 2010 | Increase (Decrease) | ||||||||||||||||||||||
% of Total | % of Total | |||||||||||||||||||||||
Operating | Operating | |||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | Amount | % | |||||||||||||||||||
Research and development |
$ | 1,098 | 31 | % | $ | 2,379 | 65 | % | $ | (1,281 | ) | -54 | % | |||||||||||
General and administrative |
1,309 | 37 | % | 1,256 | 35 | % | 53 | 4 | % | |||||||||||||||
Restructuring |
1,146 | 32 | % | | 1,146 | |||||||||||||||||||
Total operating expenses |
$ | 3,553 | 100 | % | $ | 3,635 | 100 | % | $ | (82 | ) | -2 | % | |||||||||||
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Research and development expenses
The table below summarizes the most significant components of our research and
development expenses for the periods indicated, in thousands and as a percentage of total
research and development expenses. The table also provides the changes in these components and
their percentages:
Three Months ended September 30, | ||||||||||||||||||||||||
2011 | 2010 | Increase (Decrease) | ||||||||||||||||||||||
% of Total | % of Total | |||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | Amount | % | |||||||||||||||||||
External services |
$ | 500 | 46 | % | $ | 1,510 | 63 | % | $ | (1,010 | ) | -67 | % | |||||||||||
Employee compensation and related |
472 | 43 | % | 644 | 27 | % | (172 | ) | -27 | % | ||||||||||||||
Employee stock-based compensation |
5 | 0 | % | 62 | 3 | % | (57 | ) | -92 | % | ||||||||||||||
Other |
121 | 11 | % | 163 | 7 | % | (42 | ) | -26 | % | ||||||||||||||
Total research and development |
$ | 1,098 | 100 | % | $ | 2,379 | 100 | % | $ | (1,281 | ) | -54 | % | |||||||||||
The reduction in external services expenses for the quarter ended September 30, 2011
compared to the same three month period in 2010 is primarily attributable to a reduction in
spending on all of our clinical projects for the comparable periods with the majority of the
reduction coming from ZYBRESTAT for oncology program, most prominently our anaplastic thyriod
cancer and non-small cell lung cancer projects. These two major studies have been progressing
to conclusion over the last 12 to 18 months. In addition, we experienced 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.
The reduction in employee compensation and related expenses for the quarter ended
September 30, 2011 compared to the same three month period of 2010 is due to the reductions in
our clinical project expenses noted above. 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.
We continue to evaluate next steps in the development of our clinical programs. As a
result, research and development expenses in the future could vary significantly from those
incurred in the 2011 fiscal year.
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 September 30, | ||||||||||||||||||||||||
2011 | 2010 | Increase (Decrease) | ||||||||||||||||||||||
% of Total | % of Total | |||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | Amount | % | |||||||||||||||||||
Employee compensation and related |
$ | 410 | 31 | % | $ | 456 | 36 | % | $ | (46 | ) | -10 | % | |||||||||||
Employee stock-based compensation |
46 | 4 | % | 85 | 7 | % | (39 | ) | -46 | % | ||||||||||||||
Consulting and professional services |
494 | 38 | % | 453 | 36 | % | 41 | 9 | % | |||||||||||||||
Other |
359 | 27 | % | 262 | 21 | % | 97 | 37 | % | |||||||||||||||
Total general and administrative |
$ | 1,309 | 100 | % | $ | 1,256 | 100 | % | $ | 53 | 4 | % | ||||||||||||
General and administrative expenses remained fairly flat for the comparable three month
periods ended September 30, 2011 and September 30, 2010. Employee stock-based compensation
expense can vary significantly from period to period due to the timing and vesting of option
grants. During fiscal 2011, there have not been any stock option grants to employees. The
increase in other expense for the three month period ended September 30, 2011 compared to the
same three month period ended September 30, 2010 is attributable to higher fees and taxes
related to being a public company.
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Restructuring Plan
On September 1, 2011, we announced a restructuring plan designed to focus our capital
resources on our most promising early-stage clinical programs and further reduce our cash
utilization.
We offered severance benefits to the terminated employees, and anticipate recording a
total charge of approximately $1,200,000, primarily associated with personnel-related
termination costs. In order to provide for an orderly transition, we are implementing the
reduction in work force in a phased manner. We took a restructuring charge in the third
quarter of 2011 of approximately $1,146,000, with the remainder expected to be taken over the
following two quarters as the transition is effected. Substantially all of the charge is
expected to represent cash expenditures.
Other Income and Expenses
The table below summarizes Other Income and Expense in our Statements of Operations for
the three month periods ended September 30, 2011 and September 30, 2010, in thousands:
Three months ended September 30, | Increase (Decrease) | |||||||||||||||
2011 | 2010 | Amount | % | |||||||||||||
Change in fair value of
warrants and other financial
instruments |
$ | 40 | $ | (9,893 | ) | $ | 9,933 | -100 | % | |||||||
Investment income |
1 | 3 | (2 | ) | -67 | % | ||||||||||
Other (expense) income, net |
(1 | ) | (11 | ) | 10 | -91 | % | |||||||||
Total |
$ | 40 | $ | (9,901 | ) | $ | 9,941 | -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 of our common stock warrants issued in
connection with the offerings of our common stock as discussed in the Warrants section of Note
5 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 September 30, 2011 and September
30, 2010, in thousands.
Three months ended September 30, | ||||||||
2011 | 2010 | |||||||
Committed Equity Financing Facility Warrants |
$ | | $ | 5 | ||||
Direct Registration Warrants |
40 | 99 | ||||||
Private Placement Warrants |
| (9,997 | ) | |||||
Total gain (loss) on change in fair market
value of derivatives |
$ | 40 | $ | (9,893 | ) | |||
Nine Months Ended September 30, 2011 and September 30, 2010
Revenue
We reported no licensing revenue for the nine months ended September 30, 2011 and September
30, 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
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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:
Nine Months ended September 30, | ||||||||||||||||||||||||
2011 | 2010 | Increase (Decrease) | ||||||||||||||||||||||
% of Total | % of Total | |||||||||||||||||||||||
Operating | Operating | |||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | Amount | % | |||||||||||||||||||
Research and development |
$ | 4,280 | 45 | % | $ | 9,912 | 66 | % | $ | (5,632 | ) | -57 | % | |||||||||||
General and administrative |
4,095 | 43 | % | 4,637 | 31 | % | (542 | ) | -12 | % | ||||||||||||||
Restructuring |
1,146 | 12 | % | 510 | 3 | % | 636 | 125 | % | |||||||||||||||
Total operating expenses |
$ | 9,521 | 100 | % | $ | 15,059 | 100 | % | $ | (5,538 | ) | -37 | % | |||||||||||
Research and development expenses
The table below summarizes the most significant components of our research and development
expenses for the periods indicated, in thousands and as a percentage of total research and
development expenses. The table also provides the changes in these components and their
percentages:
Nine Months ended September 30, | ||||||||||||||||||||||||
2011 | 2010 | Increase (Decrease) | ||||||||||||||||||||||
% of Total | % of Total | |||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | Amount | % | |||||||||||||||||||
External services |
$ | 2,050 | 48 | % | $ | 6,703 | 68 | % | $ | (4,653 | ) | -69 | % | |||||||||||
Employee compensation and related |
1,664 | 39 | % | 2,579 | 26 | % | (915 | ) | -35 | % | ||||||||||||||
Employee stock-based compensation |
171 | 4 | % | 109 | 1 | % | 62 | 57 | % | |||||||||||||||
Other |
395 | 9 | % | 521 | 5 | % | (126 | ) | -24 | % | ||||||||||||||
Total research and development |
$ | 4,280 | 100 | % | $ | 9,912 | 100 | % | $ | (5,632 | ) | -57 | % | |||||||||||
The reduction in external services expenses for the nine month period ended
September 30, 2011 compared to the same nine month period in 2010 is primarily attributable to
a reduction in spending on all of our clinical projects for the comparable periods with the
majority of the reduction coming from ZYBRESTAT for oncology program, most prominently our
anaplastic thyriod cancer and non-small cell lung cancer projects. These two major studies
have been progressing to conclusion over the
last 12 to 18 months. In addition, we experienced 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.
The reduction in employee compensation and related expenses for the nine month period ended
September 30, 2011 compared to the same nine month period of 2010 is due to the reductions in our
clinical project expenses noted above. 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 nine month period ended September
30, 2011 compared to the same nine 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 nine month period ended September 30, 2011 compared
to the same nine 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.
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Table of Contents
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:
Nine Months ended September 30, | ||||||||||||||||||||||||
2011 | 2010 | Increase (Decrease) | ||||||||||||||||||||||
% of Total | % of Total | |||||||||||||||||||||||
Amount | Expenses | Amount | Expenses | Amount | % | |||||||||||||||||||
Employee compensation and related |
$ | 1,395 | 34 | % | $ | 1,591 | 34 | % | $ | (196 | ) | -12 | % | |||||||||||
Employee stock-based compensation |
331 | 8 | % | 312 | 7 | % | $ | 19 | 6 | % | ||||||||||||||
Consulting and professional services |
1,460 | 36 | % | 1,909 | 41 | % | $ | (449 | ) | -24 | % | |||||||||||||
Other |
909 | 22 | % | 825 | 18 | % | $ | 84 | 10 | % | ||||||||||||||
Total general and administrative |
$ | 4,095 | 100 | % | $ | 4,637 | 100 | % | $ | (542 | ) | -12 | % | |||||||||||
The reduction in employee compensation and related expenses for the nine month period
ended September 30, 2011 compared to the same nine month period of 2010 is due to a reduction in
our average full time equivalents for the comparable periods. In February 2010, we implemented a
Company wide restructuring plan due to our decision to scale back activities in some of our
ongoing clinical projects.
The reduction in consulting and professional services expenses for the nine month period
ended September 30, 2011 compared to the same nine 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 nine 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
On September 1, 2011, we announced a restructuring plan designed to focus
our capital resources on its most promising early-stage clinical programs and further
reduce our cash utilization.
We offered severance benefits to the terminated employees, and anticipate recording a
total charge of approximately $1,200,000, primarily associated with personnel-related
termination costs. In order to provide for an orderly transition, we are implementing the
reduction in work force in a phased manner. We took a restructuring charge in the third quarter
of 2011 of approximately $1,146,000, with the remainder expected to be taken over the following
two quarters as the transition is effected. Substantially all of the charge is expected to
represent cash expenditures.
We also executed a restructuring in February 2010, designed to focus our existing
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.
Other Income and Expenses
The table below summarizes Other Income and Expense in our Statements of Operations for the
nine month periods ended September 30, 2011 and September 30, 2010, in thousands:
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Table of Contents
Nine months ended September 30, | Increase (Decrease) | |||||||||||||||
2011 | 2010 | Amount | % | |||||||||||||
Change in fair value of
warrants and other financial
instruments |
$ | 2,219 | $ | (6,987 | ) | $ | 9,206 | -132 | % | |||||||
Investment income |
3 | 14 | (11 | ) | -79 | % | ||||||||||
Other (expense) income, net |
(9 | ) | 5 | (14 | ) | -280 | % | |||||||||
Total |
$ | 2,213 | $ | (6,968 | ) | $ | 9,181 | -132 | % | |||||||
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 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
nine month periods ended September 30, 2011 and September 30, 2010, in thousands.
Nine months ended September 30, | ||||||||
2011 | 2010 | |||||||
Committed Equity Financing Facility Warrants |
$ | 3 | $ | 95 | ||||
Direct Registration Warrants |
99 | 2,077 | ||||||
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 | (4,726 | ) | |||||
Total gain (loss) on change in fair market
value of derivatives |
$ | 2,219 | $ | (6,987 | ) | |||
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 September 30, 2011, we had an accumulated deficit of
approximately $215,008,000. 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 $12,664,000 at September 30, 2011.
The following table summarizes our cash flow activities for the periods indicated, in
thousands:
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Nine months ended September 30, | ||||||||
2011 | 2010 | |||||||
Operating activities: |
||||||||
Net loss |
$ | (7,308 | ) | $ | (22,027 | ) | ||
Non-cash adjustments to net loss |
(1,552 | ) | 7,787 | |||||
Changes in operating assets and liabilities |
(117 | ) | (3,703 | ) | ||||
Net cash used in operating activities |
(8,977 | ) | (17,943 | ) | ||||
Investing activities: |
||||||||
Change in other assets |
| 40 | ||||||
Net cash provided by investing activities |
| 40 | ||||||
Financing activities: |
||||||||
Proceeds from issuance of common stock |
17,019 | 10,425 | ||||||
Net cash provided by financing activities |
17,019 | 10,425 | ||||||
Increase (decrease) in cash and cash equivalents |
8,042 | (7,478 | ) | |||||
Cash and cash equivalents at beginning of period |
4,602 | 13,932 | ||||||
Cash and cash equivalents at end of period |
$ | 12,644 | $ | 6,454 | ||||
Non-cash adjustments to net loss in the nine month period ended September 30, 2011
consist primarily of a gain from a change in the fair value of warrants and other financial
instruments of $2,219,000, offset in part by stock compensation expense of $550,000 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 $234,000, an increase in prepaid expenses and other current assets of
$62,000 and a reduction in restricted cash of $55,000. Net cash provided by financing
activities for the nine month period ended September 30, 2011 is primarily attributable to the
sale of common stock under our at the market equity financing facility discussed below.
On September 1, 2011, we announced a restructuring plan designed to focus our capital
resources on the most promising early-stage clinical programs and further reduce our cash
utilization.
We offered severance benefits to the terminated employees, and anticipate recording a
total charge of approximately $1,200,000, primarily associated with personnel-related
termination costs. In order to provide for an orderly transition, we are implementing the
reduction in work force in a phased manner. We took a restructuring charge in the third
quarter of 2011 of approximately $1,146,000, with the remainder expected to be taken over the
following two quarters as the transition is effected. Substantially all of the charge is
expected to represent cash expenditures. Upon completion of the restructuring activities
associated with the restructuring, we expect to reduce expenses from current levels by an
annual amount of approximately $2,000,000.
During the nine months ended September 30, 2011, we sold approximately 7,707,000 shares
of common stock pursuant to an at the market (ATM) equity offering sales agreement with
McNicoll, Lewis & Vlak LLC, or MLV resulting in net proceeds to us of approximately
$17,019,000. During the nine months ended September 30, 2011, we sold approximately 7,707,000
shares of common stock pursuant to the ATM sales agreement resulting in net proceeds to us of
approximately $17,019,000. In October 2011 we sold approximately 86,000 shares of common stock
pursuant to the ATM sales agreement resulting in net proceeds of approximately $128,000.
Under our current prospectus supplement to Form S-3 dated July 8, 2011, there remains
approximately $3,700 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 and taking into consideration the
expected reductions in cash utilization resulting from our September 2011 reduction in force,
we expect our cash resources to fund operations through the first half of fiscal 2013. We are
aggressively pursuing other forms of capital infusion including public or private financing,
strategic
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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.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
At September 30, 2011, we did not hold any derivative financial instruments. As of
September 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
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Table of Contents
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
September 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, as updated in our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2011 and
June 30, 2011.
We have recently implemented a reduction in force, and now have a limited number of employees to
manage and operate our business.
As announced in September 2011, we have implemented a restructuring plan designed to focus our
capital resources on our most promising early-stage clinical programs and further reduce our
cash utilization. This restructuring plan involved a reduction in force of 11 full-time
equivalent employees, or approximately 61%. We currently have 11 full-time employees. This
reduction in force and focus on reducing cash utilization requires us to manage and operate our
business in a highly efficient manner. We cannot assure you that we will be able to retain
adequate staffing levels to run our operations and/or to accomplish all of the objectives that
we otherwise would seek to accomplish.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
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Table of Contents
Item 4. (Removed and Reserved)
Item 5. Other Information
None.
Item 6. Exhibits
10.1@
|
OXiGENE, Inc. Amended and Restated Non-Employee Director Compensation Policy, effective September 20, 2011. | |
10.2@
|
OXiGENE, Inc. 2005 Stock Plan (as amended on October 31, 2011) (incorporated by reference to Exhibit 10.1 to the Companys Form S-8 filed on October 31, 2011). | |
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 September 30, 2011, formatted in XBRL (eXtensible Business Reporting Language): (i) Condensed Balance Sheets at September 30, 2011 and December 31, 2010, (ii) Condensed Statements of Operations for the three and nine months ended September 30, 2011 and 2010, (iii) Condensed Statements of Cash Flows for the nine months ended September 30, 2011 and 2010, and (iv) Notes to Condensed Financial Statements.** |
@ | Management contract or compensatory plan or arrangement. | |
** | 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: November 10, 2011 | By: | /s/ Peter J. Langecker | ||
Peter J. Langecker | ||||
Chief Executive Officer | ||||
Date: November 10, 2011 | By: | /s/ James B. Murphy | ||
James B. Murphy | ||||
Vice President and Chief Financial Officer |
33
Table of Contents
EXHIBIT INDEX
10.1@
|
OXiGENE, Inc. Amended and Restated Non-Employee Director Compensation Policy, effective September 20, 2011. | |
10.2@
|
OXiGENE, Inc. 2005 Stock Plan (as amended on October 31, 2011) (incorporated by reference to Exhibit 10.1 to the Companys Form S-8 filed on October 31, 2011). | |
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 September 30, 2011, formatted in XBRL (eXtensible Business Reporting Language): (i) Condensed Balance Sheets at September 30, 2011 and December 31, 2010, (ii) Condensed Statements of Operations for the three and nine months ended September 30, 2011 and 2010, (iii) Condensed Statements of Cash Flows for the nine months ended September 30, 2011 and 2010, and (iv) Notes to Condensed Financial Statements.** |
@ | Management contract or compensatory plan or arrangement. | |
** | 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. |
34