ACHIEVE LIFE SCIENCES, INC. - Quarter Report: 2009 June (Form 10-Q)
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
FORM 10-Q
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2009
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 033-80623
OncoGenex Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Its Charter)
Delaware (State or Other Jurisdiction of Incorporation or Organization) |
95-4343413 (I.R.S. Employer Identification Number) |
1522 217 th Place SE, Suite 100, Bothell, Washington 98021
(Address of Principal Executive Offices)
(Address of Principal Executive Offices)
(425) 686-1500
(Registrants telephone number, including area code)
(Registrants telephone number, including area code)
Indicate by check 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 during the preceding 12 months (or for such shorter
period that the registrant was required to submit and post such files). Yes o No
o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act.
Large accelerated filer o | Accelerated filer o | Non-accelerated filer o | Smaller reporting company þ | |||
(Do not check if a smaller reporting company) |
Indicate by check mark whether the registrant is a shell company (as defined in Exchange Act Rule
12b-2). Yes o No þ
Indicate the number of shares outstanding of each of the issuers classes of common stock, as of
the latest practicable date.
Class Common Stock, $0.001 par value |
Outstanding at August 1, 2009 6,027,631 |
OncoGenex Pharmaceuticals, Inc.
Index to Form 10-Q
Index to Form 10-Q
Page | ||||||||
Number | ||||||||
3 | ||||||||
3 | ||||||||
4 | ||||||||
5 | ||||||||
6 | ||||||||
21 | ||||||||
31 | ||||||||
31 | ||||||||
32 | ||||||||
32 | ||||||||
33 | ||||||||
Items 1, 2, 3, and 5 are not applicable and therefore have been omitted |
||||||||
37 | ||||||||
Exhibit 31.1 | ||||||||
Exhibit 31.2 | ||||||||
Exhibit 32.1 | ||||||||
Exhibit 32.2 |
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PART I. FINANCIAL INFORMATION
Item 1. | Consolidated Financial Statements |
OncoGenex Pharmaceuticals, Inc.
Consolidated Balance Sheets
(Unaudited)
(a development stage enterprise)
(In thousands of U.S. dollars)
June 30, | December 31, | |||||||
2009 | 2008 | |||||||
$ | $ | |||||||
Note 1 | ||||||||
ASSETS |
||||||||
Current |
||||||||
Cash and cash equivalents |
4,196 | 7,618 | ||||||
Short-term investments [note 4] |
1,505 | 4,801 | ||||||
Amounts receivable |
30 | 153 | ||||||
Investment tax credit recoverable |
377 | 1,090 | ||||||
Prepaid expenses |
575 | 587 | ||||||
Total current assets |
6,683 | 14,249 | ||||||
Property and equipment, net |
98 | 44 | ||||||
Deferred financing charges |
93 | | ||||||
Other assets |
509 | 497 | ||||||
Total assets |
7,383 | 14,790 | ||||||
LIABILITIES AND SHAREHOLDERS EQUITY |
||||||||
Current |
||||||||
Accounts payable and accrued liabilities |
1,473 | 2,252 | ||||||
Current portion of long-term obligations [Note 6] |
717 | 632 | ||||||
Total current liabilities |
2,190 | 2,884 | ||||||
Long-term obligation, less current portion [Note 6] |
1,255 | 1,199 | ||||||
Total liabilities |
3,445 | 4,083 | ||||||
Commitments and contingencies [Note 8] |
||||||||
Common Shares: |
||||||||
$0.001 par value 11,019,930 shares authorized and
5,551,760 issued and
outstanding at June 30, 2009 and 5,544,114
issued and outstanding at December 31, 2008 |
6 | 6 | ||||||
Additional paid-in capital |
56,275 | 56,070 | ||||||
Deficit accumulated during the development stage |
(54,982 | ) | (48,009 | ) | ||||
Accumulated other comprehensive income |
2,639 | 2,640 | ||||||
Total shareholders equity |
3,938 | 10,707 | ||||||
Total liabilities and shareholders equity |
7,383 | 14,790 | ||||||
Subsequent Events [Note 11] |
See accompanying notes.
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OncoGenex Pharmaceuticals, Inc.
Consolidated Statements of Operations
(Unaudited)
(In thousands of U.S. dollars, except per share and share amounts)
Period from | ||||||||||||||||||||
26-May-00 | ||||||||||||||||||||
Three Months Ended | Six Months Ended | (inception) to | ||||||||||||||||||
June 30, | June 30, | June 30, | ||||||||||||||||||
2009 | 2008 | 2009 | 2008 | 2009 | ||||||||||||||||
$ | $ | $ | $ | $ | ||||||||||||||||
EXPENSES |
||||||||||||||||||||
Research and development |
3,588 | 1,108 | 5,282 | 1,982 | 33,890 | |||||||||||||||
General and administrative |
1,003 | 646 | 1,785 | 1,219 | 15,207 | |||||||||||||||
Total expenses |
4,591 | 1,754 | 7,067 | 3,201 | 49,097 | |||||||||||||||
OTHER INCOME (EXPENSE) |
||||||||||||||||||||
Interest income |
3 | 10 | 36 | 91 | 1,448 | |||||||||||||||
Other |
31 | (223 | ) | 55 | (300 | ) | (528 | ) | ||||||||||||
Total other income (expense) |
34 | (213 | ) | 91 | (209 | ) | 920 | |||||||||||||
Loss for the period before taxes and
extraordinary gain |
4,557 | 1,967 | 6,976 | 3,410 | 48,177 | |||||||||||||||
Income tax expense (recovery) |
6 | 201 | (4 | ) | 415 | 104 | ||||||||||||||
Loss before extraordinary gain |
4,563 | 2,168 | 6,972 | 3,825 | 48,281 | |||||||||||||||
Extraordinary gain [note 2] |
| | | | 4,428 | |||||||||||||||
Net loss |
4,563 | 2,168 | 6,972 | 3,825 | 43,853 | |||||||||||||||
Redeemable convertible preferred share
accretion |
| 780 | | 1,556 | 11,129 | |||||||||||||||
Loss attributable to common shareholders |
4,563 | 2,948 | 6,972 | 5,381 | 54,982 | |||||||||||||||
Basic and diluted loss per common share
[note 5[e]] |
0.82 | 24.81 | 1.26 | 45.29 | ||||||||||||||||
Weighted average number of common
shares [note 5[e]] |
5,550,547 | 118,801 | 5,548,369 | 118,801 |
See accompanying notes.
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OncoGenex Pharmaceuticals, Inc.
Consolidated Statements of Cash Flows
(Unaudited)
(In thousands of U.S. dollars)
Period from | ||||||||||||
26-May-00 | ||||||||||||
Six months ended | (inception) to | |||||||||||
June 30, | June 30, | |||||||||||
2009 | 2008 | 2009 | ||||||||||
$ | $ | $ | ||||||||||
OPERATING ACTIVITIES |
||||||||||||
Loss for the period |
(6,972 | ) | (3,825 | ) | (43,853 | ) | ||||||
Add items not involving cash |
||||||||||||
Extraordinary gain |
| | (4,428 | ) | ||||||||
Depreciation and amortization |
24 | 28 | 451 | |||||||||
Stock-based collaboration expense |
| | 1,758 | |||||||||
Stock-based compensation [Note 5[c]] |
173 | 111 | 908 | |||||||||
Accrued interest on convertible debenture |
| 360 | 505 | |||||||||
Changes in non-cash working capital items |
||||||||||||
Amounts receivable |
123 | (9 | ) | 250 | ||||||||
Investment tax credit recoverable |
713 | 549 | (376 | ) | ||||||||
Prepaid expenses |
12 | 40 | (283 | ) | ||||||||
Other assets |
12 | | (117 | ) | ||||||||
Accounts payable and accrued liabilities |
(779 | ) | 387 | (1,977 | ) | |||||||
Lease obligation |
141 | | (112 | ) | ||||||||
Taxes payable on preferred shares |
| 314 | | |||||||||
Cash used in operating activities |
(6,553 | ) | (2,045 | ) | 47,274 | |||||||
FINANCING ACTIVITIES |
||||||||||||
Cash paid on fractional shares eliminated on reverse
share split |
| | (3 | ) | ||||||||
Proceeds from issuance of common stock under stock
option and employee purchase plans |
32 | | 156 | |||||||||
Issuance of preferred shares, net of share issue costs |
| | 26,719 | |||||||||
Issuance of common shares, net of share issue costs |
| | 146 | |||||||||
Issuance of convertible debentures net of issue costs |
| | 4,442 | |||||||||
Cash provided by financing activities |
32 | 0 | 31,460 | |||||||||
INVESTING ACTIVITIES |
||||||||||||
Purchase of investments |
(1,512 | ) | | (90,532 | ) | |||||||
Proceeds from sale of investments |
4,780 | 495 | 106,364 | |||||||||
Purchase of property and equipment |
(13 | ) | (4 | ) | (404 | ) | ||||||
Cash received on reverse takeover of Sonus |
| | 5,464 | |||||||||
Transaction fees on reverse takeover of Sonus |
| (479 | ) | (807 | ) | |||||||
Cash provided by investing activities |
3,255 | 12 | 20,085 | |||||||||
Effect of exchange rate changes on cash and cash
equivalents |
(156 | ) | (26 | ) | (75 | ) | ||||||
Increase (decrease) in cash and cash equivalents
during the period |
(3,422 | ) | (2,059 | ) | 4,196 | |||||||
Cash and cash equivalents, beginning of the period |
7,618 | 4,626 | | |||||||||
Cash and cash equivalents, end of the period |
4,196 | 2,567 | 4,196 | |||||||||
Supplemental cash flow information |
||||||||||||
Property and equipment acquired under lease obligation |
65 | | 65 |
See accompanying notes.
5
Table of Contents
OncoGenex Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
(Unaudited)
1. NATURE OF BUSINESS AND BASIS OF PRESENTATION
OncoGenex Pharmaceuticals, Inc. (the Company or OncoGenex) is a development stage enterprise
committed to the development and commercialization of new therapies that address unmet needs in the
treatment of cancer. The Company was incorporated in the state of Delaware and, together with its
subsidiaries, has a facility in Bothell, Washington for administrative, clinical and regulatory
operations and an office in Vancouver, BC for administrative, pre-clinical and
manufacturing-related operations.
On August 21, 2008, Sonus Pharmaceuticals, Inc. (Sonus) completed a transaction (the
Arrangement) with OncoGenex Technologies Inc., (OncoGenex Technologies) whereby Sonus acquired
all of the outstanding preferred shares, common shares and convertible debentures of OncoGenex
Technologies. Sonus changed its name to OncoGenex Pharmaceuticals, Inc. and was listed on the
Nasdaq Capital Market under the ticker symbol OGXI. These consolidated financial statements account
for the Arrangement between Sonus and OncoGenex Technologies as a reverse acquisition, whereby
OncoGenex Technologies is deemed to be the acquiring entity from an accounting perspective.
The unaudited financial statements have been prepared in accordance with generally accepted
accounting principles for interim financial information and with the instructions to Form 10-Q.
Accordingly, they do not include all of the information and footnotes required to be presented for
complete financial statements. The accompanying unaudited consolidated financial statements reflect
all adjustments (consisting only of normal recurring items) which are, in the opinion of
management, necessary for a fair presentation of the results for the interim periods presented. The
accompanying consolidated Balance Sheet at December 31, 2008 has been derived from the audited
consolidated financial statements included in the Companys Annual Report on Form 10-K for the year
then ended. The consolidated financial statements and related disclosures have been prepared with
the assumption that users of the interim financial information have read or have access to the
audited consolidated financial statements for the preceding fiscal year. Accordingly, these
financial statements should be read in conjunction with the audited consolidated financial
statements and the related notes thereto included in the Annual Report on Form 10-K for the year
ended December 31, 2008 and filed with the Securities and Exchange Commission (SEC) on March 11,
2009.
We are a development stage enterprise and we require additional funding to support our planned
operations, including our planned phase 3 clinical trials of OGX-011 in patients with CRPC. We may
obtain additional funding through executing a partnership or collaboration agreement with a third
party that has sufficient resources to fund the development of our product candidates, or the
licensing or sale of certain of our product candidates, or through private or public offerings of
our equity securities or debt financings.
These consolidated financial statements include the accounts of the Company and its wholly owned
subsidiaries, OncoGenex Technologies and OncoGenex, Inc. Inter-company accounts and transactions
have been eliminated.
2. REVERSE TAKEOVER
The consolidated financial statements account for the Arrangement between Sonus and OncoGenex
Technologies, whereby Sonus acquired all of the outstanding preferred shares, common shares and
convertible debentures of OncoGenex Technologies, as a reverse takeover wherein OncoGenex
Technologies is deemed to be the acquiring entity from an accounting perspective. The consolidated
results of operations of the Company include the results of operations of the combined company for
the three and six month periods ended June 30, 2009. The consolidated results of operations for the
three and six month periods ended June 30, 2008 include only the consolidated results of operations of OncoGenex
Technologies and do not include historical results of Sonus.
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On August 12, 2008, OncoGenex Technologies stockholders approved the Arrangement and on August 19,
2008, Sonus stockholders approved both the transaction and a one-for-eighteen reverse stock split
of its common stock. The reverse stock split occurred immediately prior to the completion of the
Arrangement. Resulting fractional shares were eliminated. All information in this report relating
to the number of shares, price per share, and per share amounts of common stock are presented on a
post-split basis.
Under the purchase method of accounting, Sonus outstanding shares of common stock were valued
using the average closing price on Nasdaq of $5.04 for the two days prior through to the two days
subsequent to the announcement of the transaction on May 27, 2008. There were 2,059,898 shares of
common stock outstanding, as adjusted for the reverse stock split, on August 20, 2008, immediately
prior to closing. The fair value of the Sonus outstanding stock options were determined using the
Black-Scholes option pricing model with the following assumptions: stock price of $4.86, volatility
of 57.67% to 89.48%, risk-free interest rate of 1.73% to 3.89%, and expected lives ranging from
0.05 to 4.79 years. The fair value of the Sonus outstanding warrants were determined using the
Black-Scholes option pricing model with the following assumptions: stock price of $4.86, volatility
of 58.71%, risk-free interest rate 3.89%, and expected lives ranging from 0.99 to 1.08 years.
The final purchase price is summarized as follows (in thousands):
Sonus common stock |
$ | 10,385 | ||
Fair value of options and warrants assumed |
71 | |||
Transaction costs of OncoGenex |
807 | |||
Total purchase price |
$ | 11,263 |
Under the purchase method of accounting, the total purchase price as shown in the table above is
allocated to the Sonus net tangible and identifiable intangible assets acquired and liabilities
assumed based on their fair values as of the date of the completion of the transaction. The final
purchase price allocation is as follows (in thousands):
Cash |
$ | 5,464 | ||
Marketable securities |
14,808 | |||
Accounts receivable |
6 | |||
Interest receivable |
273 | |||
Other current assets |
175 | |||
Furniture and equipment |
1,186 | |||
Other long term assets |
497 | |||
Intangible assets |
280 | |||
Accounts payable |
(35 | ) | ||
Accrued expenses excluding severance payable |
(652 | ) | ||
Severance payable to employees as part of restructuring |
(1,322 | ) | ||
Severance payable to senior executives |
(1,440 | ) | ||
Excess facility loss |
(2,083 | ) | ||
Negative goodwill |
(5,894 | ) | ||
Total purchase price |
$ | 11,263 |
In accordance with SFAS 141, Business Combinations any excess of fair value of acquired net
assets over purchase price (negative goodwill) has been recognized as an extraordinary gain in the
period the transaction was completed. The excess has been allocated as a pro rata reduction of the
amounts that otherwise would have been assigned to the non-current acquired assets. Prior to
allocation of the excess negative goodwill OncoGenex has reassessed whether all acquired assets and
assumed liabilities have been identified and recognized and performed remeasurements to verify that
the consideration paid, assets acquired, and liabilities assumed have been properly valued. The
remaining excess has been recognized as an extraordinary gain. Any subsequent adjustments to the
extraordinary gain resulting from the changes to the purchase price allocation shall be recognized
as an extraordinary item.
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The pro rata reduction of non-current and intangible assets acquired is as follows (in thousands):
Negative goodwill |
$ | (5,894 | ) | |
Furniture and equipment |
1,186 | |||
Intangible assets |
280 | |||
Excess negative goodwill |
$ | (4,428 | ) | |
Pro Forma Results of Operations
The results of operations of Sonus are included in OncoGenex consolidated financial statements
from the date of the completion of the Arrangement on August 21, 2008. The following table presents
pro forma results of operations and gives effect to the business combination transaction as if the
transaction was consummated at the beginning of the period presented. The unaudited pro forma
results of operations are not necessarily indicative of what would have occurred had the business
combination been completed at the beginning of the retrospective periods or of the results that may
occur in the future.
For the six | ||||
months ended | ||||
June 30, | ||||
(In thousands, except shares and loss per share) | 2008 | |||
$ | ||||
Revenue |
$ | | ||
Net loss applicable to common shareholders |
$ | (11,044 | ) | |
Net loss per share-basic and diluted |
$ | (92.96 | ) | |
Weighted average shares |
118,801 |
3. ACCOUNTING POLICIES
Recently Adopted Accounting Policies
In November 2007, the Emerging Issues Task Force (EITF) issued EITF Issue 07-01, Accounting for
Collaborative Arrangements, or EITF No. 07-01. EITF No. 07-01 requires collaborators to present
the results of activities for which they act as the principal on a gross basis and report any
payments received from (made to) other collaborators based on other applicable GAAP or, in the
absence of other applicable GAAP, based on analogy to authoritative accounting literature or a
reasonable, rational, and consistently applied accounting policy election.
Further, EITF No. 07-01 clarified that the determination of whether transactions within a
collaborative arrangement are part of a vendor-customer (or analogous) relationship subject to
Issue 01-9, Accounting for Consideration Given by a Vendor to a Customer. EITF No. 07-01 is
effective for fiscal years beginning after December 15, 2008 and was adopted by the Company on January 1, 2009. The adoption of EITF
07-01 did not have a material impact on the consolidated financial position, results of operations
or cash flows.
In December 2007, the Financial Accounting Standards Board (FASB) issued SFAS No. 141 (Revised
2007), Business Combinations, or SFAS No. 141R. SFAS No. 141R will change the accounting for
business combinations. Under SFAS No. 141R, an acquiring entity will be required to recognize all
the assets acquired and liabilities assumed in a transaction at the acquisition-date fair value
with limited exceptions. SFAS No. 141R will change the accounting treatment and disclosure for
certain specific items in a business combination. SFAS No. 141R applies prospectively to business
combinations for which the acquisition date is on or after the beginning of the first annual
reporting period beginning on or after December 15, 2008. The adoption of SFAS No. 141R has not had
a material impact on the Companys consolidated financial position, results of operations or cash
flows.
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In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated Financial
Statements An Amendment of ARB No. 51, or SFAS No. 160. SFAS No. 160 establishes new accounting
and reporting standards for the noncontrolling interest in a subsidiary and for the deconsolidation
of a subsidiary. SFAS No. 160 is effective for fiscal years beginning on or after December 15, 2008
and was adopted by the Company on January 1, 2009. The adoption of SFAS No. 160 has not had a
material impact on the Companys consolidated financial position, results of operations or cash
flows.
In March 2008, the FASB issued SFAS No. 161, Disclosures about Derivative Instruments and Hedging
Activities. SFAS No. 161 amends and expands the disclosure requirements of SFAS No. 133,
Accounting for Derivative Instruments and Hedging Activities. It requires qualitative disclosures
about objectives and strategies for using derivatives, quantitative disclosures about fair value
amounts of gains and losses on derivative instruments, and disclosures about credit-risk-related
contingent features in derivative agreements. In September 2008, the FASB issued FASB Staff
Position (FSP) FSP FAS 133-1 and FIN 45-4, Disclosures about Credit Derivatives and Certain
Guarantees: An Amendment of FASB Statement No. 133 and FASB Interpretation No. 45; and
Clarification of the Effective Date of FASB Statement No. 161. This FSP amends FASB Statement No.
133, Accounting for Derivative Instruments and Hedging Activities, to require disclosures by
sellers of credit derivatives, including credit derivatives embedded in a hybrid instrument. This
FSP also amends FASB Interpretation No. 45, Guarantors Accounting and Disclosure Requirements for
Guarantees, Including Indirect Guarantees of indebtedness of Others, to require an additional
disclosure about the current status of the payment/performance risk of a guarantee. Further, this
FSP clarifies the Boards intent about the effective date of FASB Statement No. 161, Disclosures
about Derivative Instruments and Hedging Activities. This statement is effective for financial
statements issued for fiscal years beginning after November 15, 2008 and was adopted by the Company
on January 1, 2009. The adoption of these pronouncements has not had a material impact on the
Companys consolidated financial position, results of operations or cash flows.
In April 2008, the FASB issued FSP FAS 142-3, Determination of Useful Life of Intangible Assets
(FSP 142-3). FSP 142-3 amends the factors that should be considered in developing the renewal or
extension assumptions used to determine the useful life of a recognized intangible asset under FAS
142, Goodwill and Other Intangible Assets. FSP 142-3 also requires expanded disclosure regarding
the determination of intangible asset useful lives. FSP 142-3 is effective for fiscal years
beginning after December 15, 2008 and was adopted by the Company on January 1, 2009. The adoption
of FSP 142-3 has not had a material impact on the Companys consolidated financial position,
results of operations or cash flows.
In May 2008, the FASB issued FASB FSB Accounting Principles Board (APB) Opinion No. 14-1,
Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including
Partial Cash Settlement) (FSB APB 14-1). The FSP will require cash settled convertible debt to
be separated into debt and equity components at issuance and a value to be assigned to each. The
value assigned to the debt component will be the estimated fair value, as of the issuance date, of
a similar bond without the conversion feature. The difference between the bond cash proceeds and
this estimated fair value will be recorded as a debt discount and amortized to interest expense
over the life of the bond. FSP APB 14-1 was adopted by the Company on January 1, 2009. The adoption of FSB APB 14-1 has not had a
material impact on the Companys consolidated financial position, results of operations, cash flows
or earnings per share.
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In June 2008, the FASB issued FSP EITF 03-6-1, Determining Whether Instruments Granted in
Share-Based Payment Transactions Are Participating Securities (FSP EITF 03-6-1). FSP EITF 03-6-1
addresses whether instruments granted in share-based payment transactions are participating
securities prior to vesting and, therefore, need to be included in the earnings allocation in
computing earnings per share under the two-class method as described in SFAS No. 128, Earnings per
Share. Under the guidance in FSP EITF 03-6-1, unvested share-based payment awards that contain
non-forfeitable rights to dividends or dividend equivalents (whether paid or unpaid) are
participating securities and shall be included in the computation of earnings per share pursuant to
the two-class method. FSP EITF 03-6-1 is effective for fiscal years beginning after December 15,
2008 and was adopted by the Company on January 1, 2009. All prior-period earnings per share amounts
presented shall be adjusted retrospectively. The adoption of FSP EITF 03-6-1 has not had a material
impact on the consolidated financial position, results of operations or cash flows.
In June 2008, the FASB ratified the consensus reached by the EITF on Issue No. 07-5, Determining
Whether an Instrument (or Embedded Feature) Is Indexed to an Entitys Own Stock (EITF No. 07-5).
EITF No. 07-5 provides guidance for determining whether an equity-linked financial instrument (or
embedded feature) is indexed to an entitys own stock. EITF No. 07-5 applies to any freestanding
financial instrument or embedded feature that has all of the characteristics of a derivative or
freestanding instrument that is potentially settled in an entitys own stock (with the exception of
share-based payment awards within the scope of SFAS 123(R)). To meet the definition of indexed to
own stock, an instruments contingent exercise provisions must not be based on (a) an observable
market, other than the market for the issuers stock (if applicable), or (b) an observable index,
other than an index calculated or measured solely by reference to the issuers own operations, and
the variables that could affect the settlement amount must be inputs to the fair value of a
fixed-for-fixed forward or option on equity shares. EITF No. 07-5 is effective for fiscal years
beginning after December 15, 2008 and was adopted by the Company on January 1, 2009. The adoption
of EITF No. 07-5 has not resulted in a material change to the classification or measurement of its
financial instruments.
In December 2008, the EITF issued EITF Issue No. 08-7, Accounting for Defensive Intangible Assets
(EITF 08-7). This issue clarifies the accounting for defensive assets, which are separately
identifiable intangible assets acquired in an acquisition which an entity does not intend to
actively use but does intend to prevent others from using. EITF 08-7 requires an acquirer to
account for these assets as a separate unit of accounting, which should be amortized to expense
over the period the asset diminishes in value. This issue is effective for intangible assets
acquired on or after the beginning of the first annual reporting period beginning on or after
December 15, 2008. Accordingly, the Company adopted EITF 08-7 on January 1, 2009. The adoption of
EITF No. 08-7 has not had a material impact on the consolidated financial position, results of
operations or cash flows.
In April 2009, the FASB issued FSP SFAS 141R-1 Accounting for Assets Acquired and Liabilities
Assumed in a Business Combination That Arise from Contingencies, (FSP SFAS 141R-1). This FSP amends
and clarifies SFAS No. 141 (revised 2007), Business Combinations (SFAS 141R), to require that an
acquirer recognize at fair value, at the acquisition date, an asset acquired or a liability assumed
in a business combination that arises from a contingency if the acquisition-date fair value of that
asset or liability can be determined during the measurement period. If the acquisition-date fair
value of such an asset acquired or liability assumed cannot be determined, the acquirer should
apply the provisions of SFAS 5, Accounting for Contingencies, to determine whether the contingency
should be recognized at the acquisition date or after it. FSP SFAS 141R-1 is effective for assets
or liabilities arising from contingencies in business combinations for which the acquisition date
is after the beginning of the first annual reporting period beginning after December 15, 2008.
Accordingly, the Company adopted EITF 08-7 effective January 1, 2009. The adoption of FSP SFAS 141R-1 has not had a material impact on the consolidated
financial position, results of operations or cash flows.
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In April 2009, the FASB issued FSP FAS No. 115-2 and FAS No. 124-2, which modify the
other-than-temporary impairment guidance for debt securities through increased consistency in the
timing of impairment recognition and enhanced disclosures related to the credit and noncredit
components of impaired debt securities that are not expected to be sold. In addition, increased
disclosures are required for both debt and equity securities regarding expected cash flows, credit
losses, and an aging of securities with unrealized losses. FSP FAS No. 115-2 and FAS No. 124-2
become effective for interim and annual reporting periods that end after June 15, 2009, and were
adopted in our second quarter of 2009. The adoption of FSP FAS No. 115-2 and FAS No. 124-2 has not
had a material impact on the consolidated financial position, results of operations or cash flows.
In April 2009, the FASB issued FSP FAS No. 107-1 and APB Opinion No. 28-1, which require fair value
disclosures for financial instruments that are not reflected in the consolidated Balance Sheets at
fair value. Prior to the issuance of FSP FAS No. 107-1 and APB Opinion No. 28-1, the fair values of
those assets and liabilities were disclosed only once each year. With the issuance of FSP FAS No.
107-1 and APB Opinion No. 28-1, we will now be required to disclose this information on a quarterly
basis, providing quantitative and qualitative information about fair value estimates for all
financial instruments not measured in the consolidated Balance Sheets at fair value. FSP FAS No.
107-1 and APB Opinion No. 28-1 become effective for interim reporting periods that end after June
15, 2009, and were adopted in our second quarter of 2009. The adoption of FSP FAS No. 107-1 and APB
Opinion No. 28-1 has not had a material impact on the consolidated financial position, results of
operations or cash flows.
In April 2009, the FASB issued FSP FAS No. 157-4, which clarifies the methodology used to determine
fair value when there is no active market or where the price inputs being used represent distressed
sales. FSP FAS No. 157-4 also reaffirms the objective of fair value measurement, as stated in FAS
No. 157, Fair Value Measurements, which is to reflect how much an asset would be sold for in an
orderly transaction. It also reaffirms the need to use judgment to determine if a formerly active
market has become inactive, as well as to determine fair values when markets have become inactive.
FSP FAS No. 157-4, which is applied prospectively, is effective for interim and annual reporting
periods ending after June 15, 2009, and was adopted in our second quarter of 2009. The adoption of
FSP FAS No. 157-4 has not had a material impact on the consolidated financial position, results of
operations or cash flows.
In May 2009, the FASB issued SFAS No. 165, Subsequent Events. SFAS No. 165 was issued in order to
establish principles and requirements for reviewing and reporting subsequent events and requires
disclosure of the date through which subsequent events are evaluated and whether the date
corresponds with the time at which the financial statements were available for issue (as defined)
or were issued. SFAS No. 165 is effective for interim reporting periods ending after June 15, 2009,
and was adopted in our second quarter of 2009. In accordance with SFAS no. 165 it is the Companys
policy to review and report subsequent events up to the day prior to the issuance of the financial
statements. The adoption of SFAS No. 165 has not had a material impact on the consolidated
financial position, results of operations or cash flows.
Recent Accounting Pronouncements
In June 2009, the FASB issued SFAS No. 168, The FASB Accounting Standards
CodificationTM and the Hierarchy of Generally Accepted Accounting
Principlesa replacement of FASB Statement No. 162, (SFAS 168). SFAS 168 replaces SFAS No. 162,
The Hierarchy of Generally Accepted Accounting Principles, and establishes the FASB Accounting
Standards CodificationTM (Codification) as the source of authoritative
accounting principles recognized by the FASB to be applied by nongovernmental entities in the
preparation of financial statements in conformity with GAAP. Rules and interpretive releases of the
SEC under authority of federal securities laws are also sources of authoritative GAAP for SEC
registrants. The FASB will no longer issue new standards in the form of Statements, FASB Staff
Positions, or Emerging Issues Task Force Abstracts; instead the FASB will issue Accounting Standards Updates.
Accounting Standards Updates will not be authoritative in their own right as they will only serve
to update the Codification. The issuance of SFAS 168 and the Codification does not change GAAP.
SFAS 168 becomes effective for the Company for the period ending September 30, 2009. Management has
determined that the adoption of SFAS 168 will not have an impact on the Financial Statements.
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In June 2009, the FASB issued SFAS No. 167, Amendments to FASB Interpretation No. 46(R), (SFAS
167). SFAS 167 amends FASB Interpretation No. 46 (Revised December 2003), Consolidation of
Variable Interest Entitiesan interpretation of ARB No. 51, (FIN 46(R)) to require an enterprise
to perform an analysis to determine whether the enterprises variable interest or interests give it
a controlling financial interest in a variable interest entity; to require ongoing reassessments of
whether an enterprise is the primary beneficiary of a variable interest entity; to eliminate the
quantitative approach previously required for determining the primary beneficiary of a variable
interest entity; to add an additional reconsideration event for determining whether an entity is a
variable interest entity when any changes in facts and circumstances occur such that holders of the
equity investment at risk, as a group, lose the power from voting rights or similar rights of those
investments to direct the activities of the entity that most significantly impact the entitys
economic performance; and to require enhanced disclosures that will provide users of financial
statements with more transparent information about an enterprises involvement in a variable
interest entity. SFAS 167 becomes effective for the Company on January 1, 2010. Management is
currently evaluating the potential impact of SFAS 167 on the financial statements.
In June 2009, the FASB issued SFAS No. 166, Accounting for Transfers of Financial Assetsan
amendment of FASB Statement No. 140, (SFAS 166). SFAS 166 amends various provisions of SFAS No.
140, Accounting for Transfers and Servicing of Financial Assets and Extinguishments of
Liabilitiesa replacement of FASB Statement No. 125, by removing the concept of a qualifying
special-purpose entity and removes the exception from applying FIN 46(R) to variable interest
entities that are qualifying special-purpose entities; limits the circumstances in which a
transferor derecognizes a portion or component of a financial asset; defines a participating
interest; requires a transferor to recognize and initially measure at fair value all assets
obtained and liabilities incurred as a result of a transfer accounted for as a sale; and requires
enhanced disclosure; among others. SFAS 166 becomes effective for the Company on January 1, 2010.
Management is currently evaluating the potential impact of SFAS 166 on the financial statements.
4. FAIR VALUE MEASUREMENTS
With the adoption of SFAS No. 157, beginning January 1, 2008, assets and liabilities recorded at
fair value in the balance sheets are categorized based upon the level of judgment associated with
the inputs used to measure their fair value. For certain of the Companys financial instruments
including cash and cash equivalents, amounts receivable, and accounts payable the carrying values
approximate fair value due to their short-term nature.
SFAS No. 157 specifies a hierarchy of valuation techniques based on whether the inputs to those
valuation techniques are observable or unobservable. In accordance with SFAS No. 157, these inputs
are summarized in the three broad levels listed below:
|
Level 1 | Quoted prices in active markets for identical securities; | ||
|
Level 2 | Other significant observable inputs that are observable through corroboration with market data (including quoted prices in active markets for similar securities); | ||
|
Level 3 | Significant unobservable inputs that reflect managements best estimate of what market participants would use in pricing the asset or liability. |
As quoted prices in active markets are not readily available, the Company obtains estimates for the
fair value of financial instruments through independent pricing service providers.
In determining the appropriate levels, the Company performed a detailed analysis of the assets and
liabilities that are subject to SFAS No. 157.
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The Company invests its excess cash in accordance with investment guidelines that limit the credit
exposure to any one financial institution other than securities issued by the U.S. Government. The
guidelines also specify that the financial instruments be issued by institutions with strong credit
ratings. These securities are generally not collateralized and mature within one year.
A description of the valuation techniques applied to the Companys marketable securities measured
at fair value on a recurring basis follows.
Financial Instruments
Government Debt Securities
U.S. Government Securities. U.S. government securities are valued using quoted market
prices. Valuation adjustments are not applied. Accordingly, U.S. government securities are
categorized in Level 1 of the fair value hierarchy.
U.S. Agency Securities. U.S. agency securities are comprised of two main categories
consisting of callable and non-callable agency issued debt securities. Non-callable agency issued
debt securities are generally valued using quoted market prices. Callable agency issued debt
securities are valued by benchmarking model-derived prices to quoted market prices and trade data
for identical or comparable securities. Actively traded non-callable agency issued debt securities
are categorized in Level 1 of the fair value hierarchy. Callable agency issued debt securities are
categorized in Level 2 of the fair value hierarchy.
Corporate and Other Debt
Corporate Bonds and Commercial Paper. The fair value of corporate bonds and commercial
paper is estimated using recently executed transactions, market price quotations (where
observable), bond spreads or credit default swap spreads adjusted for any basis difference between
cash and derivative instruments. The spread data used are for the same maturity as the bond. If the
spread data does not reference the issuer, then data that reference a comparable issuer are used.
When observable price quotations are not available, fair value is determined based on cash flow
models with yield curves, bond or single name credit default swap spreads and recovery rates based
on collateral values as significant inputs. Corporate bonds and Commercial paper are generally
categorized in Level 2 of the fair value hierarchy; in instances where prices, spreads or any of
the other aforementioned key inputs are unobservable, they are categorized in Level 3 of the
hierarchy.
The following table presents information about our assets and liabilities that are measured at fair
value on a recurring basis as at June 30, 2009, and indicates the fair value hierarchy of the
valuation techniques we utilized to determine such fair value:
(In thousands) | Level 1 | Level 2 | Level 3 | |||||||||
Corporate debt securities |
$ | | $ | | $ | | ||||||
Government debt securities |
$ | | $ | 1,006 | $ | | ||||||
Commercial paper |
$ | | $ | 1,000 | $ | | ||||||
$ | 2,006 |
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Marketable securities as at June 30, 2009 consist of the following:
Gross | Gross | |||||||||||||||
Amortized | Unrealized | Unrealized | Estimated | |||||||||||||
(In thousands) | Cost | Gain | Loss | Fair Value | ||||||||||||
Corporate debt securities |
$ | | $ | | $ | | $ | | ||||||||
Government debt
securities |
$ | 1,006 | $ | | $ | | $ | 1,006 | ||||||||
Commercial paper |
$ | 1,000 | $ | | $ | | $ | 1,000 | ||||||||
$ | 2,006 | $ | 2,006 |
$500,000 of Commercial paper in the above tables are included in cash equivalents as the securities
have maturities of 90 days or less at the time of purchase. The remaining securities all mature
within one year of the balance sheet date and are included in short-term investments.
There were no significant realized or unrealized gains or losses on the sales of marketable
securities in the six month periods ended June 30, 2009 or June 30, 2008, and no significant
unrealized gains or losses are included in accumulated other comprehensive income as at June 30,
2009.
5. COMMON SHARES
[a] Authorized
11,019,930 authorized common voting share, par value of $0.001.
[b] Issued and Outstanding Shares
As at August 20, 2008, there were 118,801 common shares of OncoGenex Technologies (on a
post-conversion basis) and 2,059,898 shares of common stock of Sonus outstanding. As part of the
Arrangement (Note 2), Sonus agreed to issue 3,449,393 shares of common stock, after accounting for
the elimination of resulting fractional shares, in exchange for all the common shares, preferred
shares and convertible debentures of OncoGenex Technologies. As a result, all common shares of
OncoGenex Technologies are now held by OncoGenex Pharmaceuticals, Inc. and have been eliminated on
consolidation.
During the six month period ended June 30, 2009 the Company issued 7,646 common shares upon
exercise of stock options (period ended June 30, 2008 nil). The Company issues new shares to
satisfy stock option exercises.
[c] Stock options
Stock Option Summary
As at June 30, 2009 the Company has reserved, pursuant to various plans, 886,297 common shares for
issuance upon exercise of stock options by employees, directors, officers and consultants of the
Company of which 138,154 are not currently subject to outstanding grants and are
available for future grants.
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Stock option transactions and the number of stock options outstanding are summarized below:
Number | ||||||||
of | Weighted | |||||||
Optioned | Average | |||||||
Common | Exercise | |||||||
Shares | Price | |||||||
# | $ | |||||||
Balance, December 31, 2008 |
723,143 | 4.88 | ||||||
Option grants |
41,300 | 7.25 | ||||||
Option cancellations |
(6,914 | ) | 7.60 | |||||
Option exercises |
(7,646 | ) | 4.24 | |||||
Option expirations |
(1,240 | ) | 3.89 | |||||
Option forfeitures |
(500 | ) | 3.00 | |||||
Balance, June 30, 2009 |
748,143 | 5.00 |
On May 12, 2009, stock options to purchase 8,260 common shares of the Company were granted to each
of the five non-executive members of the board of directors for a total grant of stock option to
purchase 41,300 common shares of the Company. The options vest quarterly over one year. The total
estimated fair value of these awards is $170,000 using the following assumptions:
Risk-free interest rates |
1.68 | % | ||
Expected dividend yield |
0 | % | ||
Expected life |
4 years | |||
Expected volatility |
76 | % |
The expected life was calculated based on the simplified method as permitted by the SECs Staff
Accounting Bulletin 110, Share-Based Payment. The Company considers the use of the simplified
method appropriate because of the lack of sufficient historical exercise data following the reverse
takeover of Sonus. The computation of expected volatility was based on the historical volatility of
comparable companies from a representative peer group selected based on industry and market
capitalization. The risk-free interest rate was based on a U.S. Treasury instrument whose term is
consistent with the expected life of the stock options. In addition to the assumptions above, as
required under SFAS 123R, management made an estimate of expected forfeitures and is recognizing
compensation costs only for those equity awards expected to vest.
The results for the periods set forth below included share-based compensation expense in the
following expense categories of the consolidated statements of operations:
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
(In thousands) | 2009 | 2008 | 2009 | 2008 | ||||||||||||
$ | $ | $ | $ | |||||||||||||
Research and development |
22 | 21 | 45 | 42 | ||||||||||||
General and administrative |
75 | 35 | 128 | 69 | ||||||||||||
Total share-based compensation |
97 | 56 | 173 | 111 |
As at June 30, 2009 and December 31, 2008 the total unrecognized compensation expense related to
stock options granted is $736,000 and $740,000 respectively, which is expected to be recognized
into expense over a period of approximately four years.
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[d] Stock Warrants
At June 30, 2009, there were warrants outstanding to purchase 183,385 shares of common
stock at exercise prices ranging from $74.70 to $79.56 per share and expiration dates
ranging from August 2010 to October 2010.
[e] Loss per Common Share
Weighted average common shares outstanding for prior periods have been restated to reflect the
change in capital structure resulting from the transaction with Sonus.
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
(In thousands except shares and per share amounts) | 2009 | 2008 | 2009 | 2008 | ||||||||||||
Numerator |
||||||||||||||||
Loss attributable to
common shareholders
as reported |
$ | 4,563 | $ | 2,948 | $ | 6,972 | $ | 5,381 | ||||||||
Denominator |
||||||||||||||||
Weighted average
number of common
shares outstanding |
5,550,547 | 118,801 | 5,548,369 | 118,801 | ||||||||||||
Basic and diluted
loss per common
share |
$ | 0.82 | $ | 24.81 | $ | 1.26 | $ | 45.29 |
As of June 30, 2009 and December 31, 2008 a total of 931,528 and 906,528 options and warrants,
respectively, have not been included in the calculation of potential common shares as their effect
on diluted per share amounts would have been anti-dilutive.
6. SEVERANCE CHARGES AND OTHER RESTRUCTURING ACTIVITIES
As a requirement for the closing of the transaction, Sonus terminated the employment of two senior
executives. Severance payable at the date of the transaction was $1,440,000 and has been accounted
for in accordance with EITF No. 95-3, Recognition of Liabilities in Connection with a Purchase
Business Combination as part of the purchase price allocation (Note 2). The severance payable was
settled following the completion of the transaction and the amount owing at June 30, 2009 and
December 31, 2008 was nil.
On August 21, 2008, immediately following the completion of the Arrangement (note 2), the Company
reduced workforce by approximately 49% in order to implement cost-savings measures to preserve cash
while focusing on its highest potential product development programs. Severance payable at the date
of the restructuring in connection with former employees of Sonus was $1,322,000 and has been
accounted for in accordance with EITF No. 95-3, Recognition of Liabilities in Connection with a
Purchase Business Combination as part of the purchase price allocation (note 2). During 2008 the
Company made payments totalling $1,186,000 and the amount owing at December 31, 2008 was $137,000. The Company estimates
that all severance liabilities relating to transaction-related workforce reductions will be paid
out by October 2009, and the amount owing at June 30, 2009 was $23,000.
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Prior to the Arrangement, Sonus entered into a non-cancellable lease arrangement for office space
located in Bothell, Washington, which is considered to be in excess of the Companys current
requirements. The Company is currently in the process of evaluating opportunities to exit or sublet
portions of the leased space and recorded an initial restructuring charge of $2,084,000 on August
21, 2008 as part of the purchase price allocation (note 2). The liability is computed as the
present value of the difference between the remaining lease payments due less the estimate of net
sublease income and expenses and has been accounted for in accordance with EITF No. 95-3,
Recognition of Liabilities in Connection with a Purchase Business Combination. This represents
the Companys best estimate of the fair value of the liability. Subsequent changes in the liability
due to accretion, or changes in estimates of sublease assumptions, etc. will be recognized as
adjustments to restructuring charges in future periods. During 2008, $362,000 was amortized into
income, resulting in a remaining liability at December 31, 2008 of $1,722,000.
In June 2009 we revised our sublease income assumptions used to estimate the fair value of the
excess lease facility liability. This change in estimate resulted in an increase in the fair value
of our excess lease liability and a $494,000 expense recorded in June 2009 to reflect this change
in estimate. The change in estimate, had a $0.09 impact on loss per common share for the both the
three and six month periods ended June 30, 2009. The estimated fair value of the liability
remaining at June 30, 2009 with respect to excess facilities is $1,689,000.
Remaining | Amortization | Additional | Remaining | |||||||||||||||||
Liability at | Payments | of excess | Liability | Liability at | ||||||||||||||||
(In thousands) | 31-Dec-08 | made | lease facility | Recorded | June 30, 2009 | |||||||||||||||
Employee severance included in accrued
liabilities |
$ | 137 | $ | 114 | $ | | $ | | $ | 23 | ||||||||||
Current portion of excess lease facility |
$ | 632 | $ | | $ | (453 | ) | $ | 508 | $ | 687 | |||||||||
Long-term portion of excess lease facility |
$ | 1,090 | $ | | $ | (74 | ) | $ | (14 | ) | $ | 1,002 |
7. TAXES
Under FIN 48, the benefit of an uncertain tax position that is more likely than not of being
sustained upon audit by the relevant taxing authority must be recognized at the largest amount that
is more likely than not to be sustained. No portion of the benefit of an uncertain tax position may
be recognized if the position has less than a 50% likelihood of being sustained.
A reconciliation of the unrecognized tax benefits of uncertain tax positions for the quarter ended
June 30, 2009 is as follows:
(In thousands) | $ | |||
Balance as of December 31, 2008 |
1,956 | |||
Additions based on tax positions related to the current year |
125 | |||
Deductions based on tax positions related to the current year |
(276 | ) | ||
Balance as of June 30, 2009 |
1,805 |
As of June 30, 2009 unrecognized benefits of approximately $1,805,000, if recognized, would affect
the Companys effective tax rate.
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8. COMMITMENTS AND CONTINGENCIES
Isis Pharmaceuticals Inc. and University of British Columbia
Pursuant to license agreements the Company has with the University of British Columbia (UBC) and
Isis Pharmaceuticals Inc. (Isis), the Company is obligated to pay royalties on future product
sales and milestone payments of up to $9.9 million upon the achievement of specified product
development milestones. In addition, the Company is obligated to pay to UBC certain patent costs
and annual license maintenance fees for the extent of the patent life of CAD $8,000 per year.
The UBC agreements have effective dates ranging from November 1, 2001 to April 5, 2005 and each
agreement expires upon the later of 20 years from its effective date or the expiry of the last
patent licensed thereunder, unless otherwise terminated.
Unless otherwise terminated, the Isis agreements for OGX-011 and OGX-427 will continue for each
product until the later of 10 years after the date of the first commercial product sale, or the
expiration of the last to expire of any patents required to be licensed in order to use or sell the
product, unless OncoGenex Technologies abandons either OGX-011 or OGX-427 and Isis does not elect
to unilaterally continue development. The Isis agreement for OGX-225 will continue into perpetuity
unless OncoGenex Technologies abandons the product and Isis does not elect to unilaterally continue
development.
Bayer HealthCare LLC
On August 7, 2008, Sonus completed an exclusive in-licensing agreement with Bayer HealthCare LLC
(Bayer) for the right to develop, commercialize or sublicense a family of compounds known as
caspase activators presently in preclinical research. Under terms of the agreement, Sonus was
granted exclusive rights to develop two core compounds for all prophylactic and therapeutic uses in
humans. Additionally, Sonus was granted rights to all other non-core compounds covered under the
patents for use in oncology.
Under the terms of the agreement, Bayer received an upfront license fee of $450,000. OncoGenex will
make annual payments to Bayer on the anniversary date (Anniversary Payments), with an initial
payment of $100,000 paid in June 2009. The payments will increase by $25,000 each year until the
initiation of the first phase 3 clinical trial, at which point the Anniversary Payments reset to
$100,000 each year and increase by $25,000 until the Company achieves either the first New Drug
Application filing in the United States or the European Union. OncoGenex is obligated to pay
royalties ranging from 3.5% to 7.5% of net future product sales and aggregate payments of up to
$14,000,000 for clinical development and regulatory milestones. No milestone payments are triggered
prior to the initiation of a phase 3 clinical trial. OncoGenex has the option to terminate this
contract upon 60 days written notice to Bayer.
Lease Arrangements
The Company has an operating lease agreement for office space in Vancouver, Canada. The lease was
set to expire in September 2009, but was renewed in June 2009 for an additional 18 months. The
lease is now set to expire in March 2011.
Future minimum annual lease payments under the Vancouver lease are as follows:
$ | ||||
(In thousands) | ||||
2009 |
80 | |||
2010 |
163 | |||
2011 |
41 | |||
Total |
284 |
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In November 2006, prior to the Arrangement (note 2), Sonus entered into a non-cancellable operating
lease agreement for office space in Bothell, Washington, expiring in 2017 and office equipment
under two non-cancellable operating leases which expire in 2009 and 2010. In connection with the
new lease, Sonus was required to provide a cash security deposit of approximately $497,000, which
is included in Other Long Term Assets. In addition, the lease stipulates the Company must issue a
standby letter of credit for approximately $500,000 which is expected to be issued during 2009. The
Company is currently in the process of evaluating opportunities to exit or sublet portions of the
leased space and has recorded a liability in the excess facilities lease charge of $1,689,000 as at
June 30, 2009 (Note 6).
If the Company is unable to exit or sublet portions of this leased space, the future
minimum annual lease payments including excess facilities are as follows:
$ | ||||
(In thousands) | ||||
2009 |
969 | |||
2010 |
1,995 | |||
2011 |
2,055 | |||
2012 |
2,117 | |||
2013 |
2,180 | |||
remainder |
9,395 | |||
Total |
18,711 |
Consolidated rent expense for the periods ended June 30, 2009 and 2008 was $1,130,000 and $122,000
respectively.
Guarantees and Indemnifications
In November 2002 the FASB issued FASB Interpretation No. 45, (FIN 45) Guarantors Accounting and
Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others.
FIN 45 requires that upon issuance of a guarantee, the guarantor must recognize a liability for the
fair value of the obligations it assumes under that guarantee.
OncoGenex indemnifies its officers and directors for certain events or occurrences, subject to
certain limits, while the officer or director is or was serving at our request in such capacity.
The term of the indemnification period is equal to the officers or directors lifetime.
The maximum amount of potential future indemnification is unlimited; however, we have obtained
director and officer insurance that limits our exposure and may enable it to recover a portion of
any future amounts paid. We believe that the fair value of these indemnification obligations is
minimal. Accordingly, we have not recognized any liabilities relating to these obligations as of
June 30, 2009.
We have certain agreements with certain organizations with which we do business that contain
indemnification provisions pursuant to which we typically agree to indemnify the party against
certain types of third-party claims. We accrue for known indemnification issues when a loss is
probable and can be reasonably estimated. There were no accruals for or expenses related to
indemnification issues for any period presented.
9. RELATED PARTY TRANSACTIONS
The Company incurred consulting fees of $53,000 for the six month period ended June 30, 2008
respectively, payable to a former director. There were no related party transactions during the
period ended June 30, 2009, and no amounts were included in accounts payable and accrued
liabilities as at June 30, 2009. All transactions were recorded at their exchange amounts.
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10. COMPREHENSIVE INCOME (LOSS)
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
(In thousands) | 2009 | 2008 | 2009 | 2008 | ||||||||||||
$ | $ | $ | $ | |||||||||||||
Loss for the period |
4,563 | 2,168 | 6,972 | 3,825 | ||||||||||||
Reclassification of unrealized gain on
marketable securities |
| | | 1 | ||||||||||||
Unrealized loss on cash equivalents and
marketable securities |
1 | | 1 | 1 | ||||||||||||
Unrealized loss (gain) on foreign exchange |
| (43 | ) | | 68 | |||||||||||
Comprehensive loss |
4,564 | 2,125 | 6,973 | 3,895 |
11. SUBSEQUENT EVENTS
On July 24, 2009, the Company completed a registered direct offering with certain institutional
investors covering the sale of 475,000 shares of common stock at a price of $20 per share under a
shelf registration statement on Form S-3 (No. 333-160251) that was declared effective on July 17,
2009. The transaction provided net proceeds of approximately $9.4 million to OncoGenex after
deducting costs associated with the offering.
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Item 2. | Managements Discussion and Analysis of Financial Condition and Results of Operations |
INFORMATION REGARDING FORWARD LOOKING STATEMENTS
This document contains forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. These forward-looking statements involve a number of risks and
uncertainties. We caution readers that any forward-looking statement is not a guarantee of future
performance and that actual results could differ materially from those contained in the
forward-looking statement. These statements are based on current expectations of future events.
Such statements include, but are not limited to, statements about the anticipated benefits of the
Arrangement completed on August 21, 2008 between Sonus and OncoGenex Technologies, including future
financial and operating results, the combined companys plans, objectives, expectations and
intentions, costs and expenses, interest rates, outcome of contingencies, financial condition,
results of operations, liquidity, business strategies, cost savings, objectives of management and
other statements that are not historical facts. You can find many of these statements by looking
for words like believes, expects, anticipates, estimates, may, should, will, could,
plan, intend, or similar expressions in this document or in documents incorporated by reference
in this document. We intend that such forward-looking statements be subject to the safe harbors
created thereby. Examples of these forward-looking statements include, but are not limited to:
| our anticipated future capital requirements and the terms of any capital financing agreements; | ||
| progress and preliminary and future results of clinical trials; | ||
| anticipated regulatory filings, requirements and future clinical trials; | ||
| timing and amount of future contractual payments, product revenue and operating expenses; and | ||
| market acceptance of our products and the estimated potential size of these markets. |
These forward-looking statements are based on the current beliefs and expectations of our
management and are subject to significant risks and uncertainties. If underlying assumptions prove
inaccurate or unknown risks or uncertainties materialize, actual results may differ materially from
current expectations and projections. The following factors, among others, could cause actual
results to differ from those set forth in the forward-looking statements:
| future capital requirements and uncertainty of obtaining additional funding through corporate partnerships, debt or equity financings; | ||
| dependence on the development and commercialization of products; | ||
| the risk that results in humans may not be indicative of results in future studies; | ||
| the risk that results of research and preclinical studies may not be indicative of results in humans; | ||
| uncertainty relating to the timing and results of clinical trials; |
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| uncertainties regarding the safety and effectiveness of the Companys products and technologies; | ||
| the timing, expense and uncertainty associated with the development and regulatory approval process for products; | ||
| uncertainties regarding the Companys future operating results, and the risk that the Companys products will not obtain the requisite regulatory approvals to commercialize its products or that the future sales of the Companys products may be less than expected; | ||
| acceptance of our products by the medical community; | ||
| our ability to build out our product candidate pipeline through product in-licensing or acquisition activities; | ||
| the Companys dependence on key employees; | ||
| the uncertainty associated with exiting or subleasing our excess office and laboratory space; | ||
| general competitive conditions within the drug development and pharmaceutical industry; | ||
| the potential inability to integrate and realize benefits from the Arrangement; | ||
| the reliance on third parties who license intellectual property rights to the Company to comply with the terms of such agreements and to enforce, prosecute and defend such intellectual property rights; | ||
| the potential for product liability issues and related litigation; | ||
| the potential for claims arising from the use of hazardous materials in our business; | ||
| proper management of our operations will be critical to the success of the Company; | ||
| the potential inability to successfully protect and enforce our intellectual property rights; | ||
| the impact of current, pending or future legislation, regulations and legal actions in the United States, Canada and elsewhere affecting the pharmaceutical and healthcare industries; | ||
| currency fluctuation in the Companys primary markets; | ||
| volatility in the value of our common stock; | ||
| fluctuations in our operating results; | ||
| history of operating losses and uncertainty of future financial results; and | ||
| general economic conditions. |
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You are cautioned not to place undue reliance on these forward-looking statements, which speak only
as of the date of this document or, in the case of documents referred to or incorporated by
reference, the date of those documents.
All subsequent written or oral forward-looking statements attributable to us or any person acting
on our behalf are expressly qualified in their entirety by the cautionary statements contained or
referred to in this section. We do not undertake any obligation to release publicly any revisions
to these forward-looking statements to reflect events or circumstances after the date of this
document or to reflect the occurrence of unanticipated events, except as may be required under
applicable U.S. securities law. If we do update one or more forward-looking statements, no
inference should be drawn that we will make additional updates with respect to those or other
forward-looking statements.
MD&A Overview
In Managements Discussion and Analysis of Financial Condition and Results of Operations we explain
the general financial condition and the results of operations for our Company, including:
| an overview of our business; | ||
| results of operations and why those results are different from the comparative period in the prior year; and | ||
| capital resources we currently have, our need for additional capital and possible sources of additional funding for future capital requirements. |
Arrangement Agreement
As discussed in the notes to the financial statements above, during 2008, the Company completed the
Arrangement with OncoGenex Technologies and, in connection therewith, effected a one-for-eighteen
reverse stock split. All information in this report relating to the number of shares, price per
share, and per share amounts of common stock are presented on a post-reverse stock split basis.
For more information concerning the Arrangement, see the discussion of the Arrangement in
Managements Discussion and Analysis of Financial Condition and Results of Operations included in
our 2008 Annual Report on Form 10-K filed with the SEC on March 11, 2009 and note 2 to the
financial statements included in this 10-Q, both of which are incorporated by reference herein.
Overview of the Company
OncoGenex is a biopharmaceutical company committed to the development and commercialization of new
therapies that address unmet needs in the treatment of cancer. The Company has five product
candidates in its pipeline, namely, OGX-011, OGX-427, OGX-225, SN2310 and CSP-9222, with each
product candidate having a distinct mechanism of action and representing a unique opportunity for
cancer drug development.
OncoGenex product candidates OGX-011, OGX-427 and OGX-225 focus on mechanisms of treatment
resistance in cancer patients and are designed to address treatment resistance by blocking the
production of specific proteins that OncoGenex believes promote survival of tumor cells and are
over-produced in response to a variety of cancer treatments. OncoGenex aim in targeting these particular proteins
is to disable the tumor cells adaptive defenses and thereby render the tumor cells more
susceptible to attack with a variety of cancer therapies, including chemotherapy, which OncoGenex
believes will increase survival time and improve the quality of life for cancer patients. Product
candidate SN2310 is a novel camptothecin for the treatment of cancer. Camptothecins are potent
anticancer agents that belong to the family of drugs called topoisomerase I inhibitors that bind
reversibly to the TOPO-I-DNA complex causing breaks in the DNA strands during replication resulting
in cell death. Product candidate CSP-9222 is the lead compound from a family of compounds
demonstrating activation of programmed cell death in pre-clinical models that have been in-licensed
from Bayer HealthCare LLC.
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Product Candidate OGX-011
We have designed two phase 3 clinical trials to evaluate the clinical benefit of OGX- 011 in
metastatic castrate resistant prostate cancer (CRPC). OncoGenex believes that two phase 3 trials
will be required for initial product marketing approval. The two clinical trial designs are:
| Evaluating a survival benefit for OGX-011 in combination with first-line docetaxel treatment in approximately 800 men with CRPC; and |
| Evaluating a durable pain palliation benefit for OGX-011 in combination with docetaxel as second-line chemotherapy in approximately 300 men with CRPC. |
OncoGenex intends to conduct the above phase 3 trials with OGX-011 in metastatic CRPC, subject to
the receipt of additional funding.
OGX-011 has received Fast Track designation from the U.S. Food & Drug Administration (FDA) for
the treatment of progressive metastatic prostate cancer in combination with docetaxel. The FDA has
agreed on the design of two phase 3 registration trials, via the Special Protocol Assessment
(SPA) process. One trial design investigates overall survival as the primary endpoint for OGX-011
in combination with first-line chemotherapy, whereas the other trial design investigates pain
palliation as the primary endpoint for OGX-011 in combination with second-line chemotherapy.
Final results of a randomized phase 2 trial evaluating the benefit of combining OGX-011 with
first-line docetaxel chemotherapy were presented during an oral presentation at the American
Society of Clinical Oncology (ASCO) 2009 Annual Meeting. Analyses indicating a survival benefit in
patients treated with OGX-011 in combination with first-line docetaxel compared to docetaxel alone,
the latter of which being the current standard care for patients with advanced, progressive
metastatic prostate cancer, is described below:
| The median overall survival in patients with advanced metastatic prostate cancer who were treated with OGX-011 plus docetaxel in a randomized phase 2 trial was 23.8 months compared to 16.9 months for patients treated with docetaxel alone, indicating a 6.9 month survival advantage in the OGX-011 arm; |
| The unadjusted hazard ratio (HR), unadjusted hazard ratio (HR), a measure used to compare the death rates between treatment groups, was 0.61, representing a 39% lower rate of death for patients treated with OGX-011; and |
| A prospectively defined multivariate analysis indicated that the significant predictors of overall survival were treatment arm, performance status and presence of metastases other than in bone or lymph nodes. Patients treated with OGX-011 had a rate of death 51% lower than patients treated with docetaxel alone (HR=0.49; p=0.012). Additional exploratory analyses found that the lower rate of death was associated with the effect of OGX-011 treatment even when varying amounts of chemotherapy were administered (i.e. OGX-011 treatment resulted in a lower rate of death when compared to the control arm for patients receiving 6 or less cycles of chemotherapy as well as for patients receiving 10 cycles of chemotherapy). |
OGX-011 treatment was well tolerated in combination with docetaxel. There was an increase in
incidence of mild fever, chills and creatinine levels (a laboratory measure for reduced kidney
function) and a moderate to significant decrease in circulating lymphocytes in the blood (another
laboratory measure) without any increase in infection rate compared to the docetaxel arm. Due to
the final results of this randomized phase 2 trial, the phase 3 registration trial will evaluate
the overall survival benefit of OGX-011 in patients treated with first-line chemotherapy.
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Durable pain palliation defined as pain palliation of 12 weeks or greater has been observed in
another phase 2 trial evaluating patients with metastatic CRPC who progressed while receiving, or
within 6 months of completing, first-line docetaxel treatment. In this trial, 44% of patients who
were retreated with docetaxel as second-line treatment in combination with OGX-011 had durable pain
palliation. This is favorable even when compared to the 35% pain responses of 3 weeks or greater
observed in the phase 3 study registering docetaxel as first-line chemotherapy in patients with
CRPC. Due to the results of this phase 2 trial, the other phase 3 registration trial will evaluate
the durable pain palliation benefit of OGX-011 in patients treated with second-line chemotherapy.
Product Candidate OGX-427
A phase 1 trial has evaluated 41 patients with a variety of cancers, with enrollment ongoing.
OGX-427 was first evaluated as a single agent in a dose escalation manner up to 1000mg OGX-427. A
maximum tolerated dose was not identified up to and including the 1000mg dose of OGX-427
monotherapy. Subsequently, as defined by the protocol, an 800mg dose of OGX-427 in combination
with docetaxel was evaluated, to be followed by, a 1000mg OGX-427 plus docetaxel. OGX-427 is
administered as three loading doses within the first nine days and then continued weekly, with
three weeks defined as a treatment cycle, until disease progression or toxicity. In those groups
receiving OGX-427 in combination with docetaxel, 75mg/M2 docetaxel was administered on day 1 of
every 3-week cycle starting after completion of the OGX-427 loading doses.
Preliminary results of this phase 1 trial were presented during an oral presentation at the
American Society of Clinical Oncology (ASCO) 2009 Annual Meeting. Patients enrolled had a diagnosis
of breast, ovarian, prostate or non-small cell lung cancer and most had failed multiple prior
chemotherapy treatments. A median of two cycles (range of one to eight cycles) was administered.
OGX-427 treatment was well tolerated as a monotherapy. No evidence of altered cardiac activity was
observed. A majority of adverse events were mild and mainly occurred during the loading doses.
Adverse events consisted of chills, itching and fatigue in over one-third of patients. There was a
trend for increasing incidence of some mild adverse events with escalating OGX-427 doses. For
example, 33% of patients at the 200mg dose compared to 67% of patients at the 1000mg dose had mild
adverse events during the loading doses. The half-life of OGX-427 in the blood remained constant,
although there appeared to be an increase in maximum blood levels and a corresponding decease in
blood clearance of OGX-427 as doses were escalated.
The combination of 800mg OGX-427 with docetaxel was also well tolerated and escalation to 1000mg
OGX-427 with docetaxel will be evaluated next.
Circulating tumor cells (CTCs), an emerging metric to assess treatment effect, was evaluated at
baseline before treatment and during treatment. Both total and Hsp27-positive CTCs were evaluated.
Declines of 50% or greater in both total and Hsp27-positive CTCs were observed in over one-half of
the patients in each cohort and in each cancer category. Declines in Hsp27 CTCs to 5 or less cells
occurred in 27% of patients who had greater than 5 CTCs at baseline. Reduction in tumor markers
defined as declines of prostate specific antigen, or PSA, levels in prostate cancer or CA-125
levels in ovarian cancer were also observed. A reduction in PSA level was observed in 7 of 20 patients (35%) with prostate cancer and
a reduction in CA-125 levels was observed in 3 of 5 patients (60%) with ovarian cancer.
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Product Candidates OGX-225, SN2310 and CSP-9222
SN2310 was evaluated in a phase 1 clinical trial to evaluate safety in patients with advanced
cancer who have received on average three to five prior chemotherapy treatments. SN2310 has been
administered to 26 patients with various types of cancer in a phase 1 clinical trial. The phase 1
clinical trial has been completed and the dose-limiting toxicity that defined a maximum tolerated
dose in this heavily pretreated patient population has been determined. No additional trials for
SN2310 will be initiated prior to attaining additional funding through, among other things,
executing a partnership or collaboration agreement with a third party to fund the development of
OGX-011 or the licensing or sale of certain of our product candidates.
OGX-225, an inhibitor of insulin growth factor binding proteins 2 and 5, and CSP-9222 are in
pre-clinical development.
Revenues
OncoGenex has not generated any revenues from the sale of its products to date, and it does not
expect to generate any revenues from licensing or product sales unless and until it executes a
partnership or collaboration arrangement or is able to commercialize its product candidates itself.
Research and Development Expenses
Research and development (R&D) expenses consist primarily of costs for: clinical trials;
materials and supplies; facilities; personnel, including salaries and benefits; regulatory
activities; pre-clinical studies; licensing and intellectual property; and allocations of other
research and development-related costs. External research and development expenses include fees
paid to universities, hospitals and other entities that conduct certain research and development
activities and that manufacture OncoGenex product candidates for use in its clinical trials.
OncoGenex expects its research and development expenses to increase significantly in the future as
it continues to develop its product candidates. Currently, OncoGenex manages its clinical trials
through independent medical investigators at their sites and at hospitals.
A majority of the Companys expenditures to date have been related to the development of OGX-011.
Until July 2, 2008, OGX-011 was being co-developed with Isis and R&D expenses for OGX-011 were
shared on the basis of 65% OncoGenex and 35% Isis. On July 2, 2008, OncoGenex and Isis amended
their agreement to provide for unilateral development of OGX-011 by OncoGenex.
Several of the Companys clinical trials have been supported by grant funding which was received
directly by the hospitals and/or clinical investigators conducting the clinical trials allowing
OncoGenex to complete these clinical trials with minimal expense.
Since the Companys drug candidates are in the early stage of development, we cannot estimate
completion dates for development activities or when we might receive material net cash inflows from
our research and development projects.
General and Administrative Expenses
General and administrative (G&A) expenses consist primarily of salaries and related costs for
OncoGenex personnel in executive, business development, human resources, external communications,
finance and other administrative functions, as well as consulting costs, including market research
and business consulting. Other costs include professional fees for legal and accounting services,
insurance and facility costs. OncoGenex believes that G&A resources are sufficient to carry on
existing development activities. If we are successful in obtaining additional funding and
initiating a phase 3 clinical trial, OncoGenex anticipates that G&A expenses will increase
significantly in the future as it continues to expand its operating activities.
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Restructuring Activities
As discussed above in the notes to the financial statements, in connection with the closing of the
Arrangement, Sonus terminated the employment of two senior executives and reduced its workforce.
The severance payable to the terminated executives was settled following the completion of the
transaction and the amount owing at June 30, 2009 was nil. The Company estimates that all
severance liabilities relating to transaction-related workforce reductions will be paid out by
October 2009, and the amount owing at June 30, 2009 was $23,000.
Results of Operations
As discussed above, on August 21, 2008, Sonus completed the Arrangement with OncoGenex
Technologies, whereby Sonus acquired all of the outstanding preferred shares, common shares and
convertible debentures of OncoGenex Technologies. The consolidated financial statements reflect the
Arrangement as a reverse acquisition, whereby OncoGenex Technologies is deemed to be the acquiring
entity from an accounting perspective. The consolidated results of operations of the Company
include the results of operations of the combined Company for the full three and six month periods
ended June 30, 2009. The consolidated results of operations for the three and six month periods
ended June 30, 2008 include only the consolidated results of operations of OncoGenex Technologies
and do not include historical results of Sonus. This treatment and presentation is in accordance
with SFAS 141, Business Combinations. Proforma results are included in note 2 to the financial
statements.
Three Months Ended June 30, 2009 Compared to the Three Months Ended June 30, 2008
R&D expenses for the three months ended June 30, 2009 increased to $3.6 million from $1.1 million
for the three months ended June 30, 2008, due mainly to the purchase of OGX-011 drug compound from
Isis, payments made to Bayer in relation to the Caspase license, costs associated with the
development of OGX-427 and an increase in employee expenses and facility costs resulting from the
reverse takeover of Sonus. Also included in the three months ended June 30, 2008 was a Scientific
Research and Development (SRED) claim of $0.2 million which offset R&D expenses in the second
quarter of 2008. The SRED program is a Canadian federal tax incentive program that encourages
Canadian businesses to conduct research and development in Canada. Since OncoGenex Technologies
became an affiliate of a public company as a result of the Arrangement, SRED claims can now only be
applied against taxes payable.
G&A expenses for the three months ended June 30, 2009 increased to $1.0 million from $0.6 million
for the three months ended June 30, 2008, due mainly to higher employee expenses and increased
costs associated with operating as a public company.
Interest income for the three months ended June 30, 2009 decreased to $3 thousand from $10 thousand
for the three months ended June 30, 2008.
Other for the three months ended June 30, 2009 increased to $31 thousand in income from $223
thousand in expense for the three months ended June 30, 2008. The income earned in 2009 was due to
the gains on sales of equipment and foreign exchange gains, as compared to a foreign exchange
losses and convertible debenture interest in the 2008 period.
Six Months Ended June 30, 2009 Compared to the Six Months Ended June 30, 2008
R&D expenses for the six months ended June 30, 2009 increased to $5.3 million from $2.0 million for
the six months ended June 30, 2008, due mainly to the purchase of OGX-011 drug compound from Isis,
payments made to Bayer in relation to the CSP-9222 license, costs associated with the development of
OGX-427, an increase in employee expenses and higher facility costs resulting from the reverse
takeover of Sonus. Also included in the six months ended June 30, 2008 was a SRED claim of $0.5
million which offset R&D expenses in the period. Since OncoGenex Technologies became an affiliate
of a public company as a result of the Arrangement, SRED claims can now only be applied against
taxes payable.
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G&A expenses for the six months ended June 30, 2009 increased to $1.8 million from $1.2 million for
the six months ended June 30, 2008, due mainly to higher employee expenses and increased costs
associated with operating as a public company.
Interest income for the six months ended June 30, 2009 decreased to $36 thousand from $91 thousand
for the six months ended June 30, 2008. Of the $91 thousand in interest for the 2008 period, $60
thousand related to interest received from the Canada Revenue Agency in relation to the Companys
2006 Scientific Research and Development claim, while the 2009 amount includes only interest earned
on cash and cash equivalents and marketable securities.
Other for the six months ended June 30, 2009 increased to $55 thousand in income from $300 thousand
in expense for the six months ended June 30, 2008. The income earned in 2009 was due to the gains
on sales of equipment and foreign exchange gains, as compared to a foreign exchange losses and
convertible debenture interest in the 2008 period.
Liquidity and Capital Resources
OncoGenex has incurred cumulative losses attributable to common shareholders of $55 million since
the inception of OncoGenex Technologies through June 30, 2009. OncoGenex does not expect to
generate revenue from product candidates for several years. Prior to the Arrangement, Sonus funded
its operations through private and public offerings of common stock, and OncoGenex Technologies
funded its operations primarily through the private placement of its preferred shares. Cash, cash
equivalents and short term investments of $20.3 million were realized in August 2008 as a result of
the Arrangement.
As at June 30, 2009, OncoGenex had cash, cash equivalents, and short-term investments of $5.7
million in the aggregate as compared to cash, cash equivalents and short-term investments $12.4
million as at December 31, 2008. In July 2009, we received approximately $9.4 million in net
proceeds, after deducting offering expenses, for the sale of 475,000 shares of our common stock at
a price of $20 per share through a registered direct offering under a shelf registration statement
on Form S-3 (No. 333-160251) that was declared effective on July 17, 2009. As at June 30, 2009,
OncoGenex does not have any borrowing or credit facilities available to it.
Cash Flows
Cash Used in Operations
For the six months ended June 30, 2009 and 2008, net cash used in operations was $6.5 million and
$2.0 million respectively. This increase in cash used in operations in the six months ended June
30, 2009 compared to the same period in 2008 was attributable primarily to increased R&D expenses
associated with personnel and facilities assumed in the reverse takeover of Sonus, the purchase of
OGX-011 drug compound from Isis, and payments made to Bayer in relation to the Caspase license.
Cash Provided by Financing Activities
For the six months ended June 30, 2009 and 2008, net cash provided by financing activities was $35
thousand and nil respectively. All net cash provided by financing activities in the six months
ended June 30, 2009 was due to the result of proceeds from the issuance of common shares on stock
option exercises. There was no cash provided by, or used by financing activities for, the six
months ended June 30, 2008.
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Cash Used/Provided by Investing Activities
Net cash provided by investing activities for the six months ended June 30, 2009 and 2008 was $3.3
million and $12 thousand, respectively. Net cash provided by investing activities in the six months
ended June 30, 2009 and 2008 was due to transactions involving marketable securities in the normal
course of business. The related maturities and sales of those investments provide working capital
on an as-needed basis.
Operating Capital and Capital Expenditure Requirements
OncoGenex believes that its cash, cash equivalents and short-term investments will be sufficient to
fund its currently planned operations at least through 2010 including:
| continuing survival follow-up for previously announced phase 2 clinical trials of OGX-011; | ||
| completion of its phase 1 clinical trial evaluating OGX-427 as a monotherapy in patients with solid tumors; | ||
| initiation of an investigator-sponsored phase 1 clinical trial evaluating OGX-427 treatment in patient with bladder cancer; and | ||
| working capital needs, capital expenditures and general corporate purposes. |
We require additional funding to support our planned operations, including our planned phase 3
clinical trials of OGX-011 in patients with CRPC. We may seek additional funding through, among
other things, executing a partnership or collaboration agreement with a third party that has
sufficient resources to fund the development of our product candidates or the licensing or sale of
certain of our product candidates.
Our future capital requirements depend on many factors including:
| our ability to obtain additional funding through executing a partnership or collaboration agreement with a third party that has sufficient resources to fund the development of our product candidates or the licensing or sale of certain of our product candidates, or through private or public offerings of our equity securities or debt financings; | ||
| timing and costs of clinical trials, preclinical development and regulatory approvals; | ||
| timing and cost of drug discovery and research and development; | ||
| entering into new collaborative or product license agreements for products in our pipeline; and | ||
| costs related to obtaining, defending and enforcing patents. |
There can be no assurance that we will be able to obtain additional funding on terms favorable to
us, or at all. Our ability to obtain financing is particularly uncertain due to the current
widespread economic downturn. If we are unable to obtain sufficient funds to satisfy our cash requirements within the
required timeframe on terms favorable to us, we may be forced to curtail development activities and
other operations or dispose of assets. Such events would materially and adversely affect our
financial position and results of operations. In the event that such steps are not sufficient, or
we believe that they will not be sufficient, we may be required to discontinue our operations.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet financing arrangements at June 30, 2009.
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Inflation
We not believe that inflation has had a material impact on our business and operating results
during the periods presented.
Contingencies and Commitments
We previously disclosed certain contractual obligations and contingencies and commitments relevant
to the Company within the financial statements and Management Discussion and Analysis of Financial
Condition and Results of Operations in our Annual Report on Form 10-K for the year ended December
31, 2008, as filed with the SEC on March 11, 2009. There have been no significant changes to our
Contractual Obligations table in Part II, Item 7, Managements Discussion and Analysis of
Financial Condition and Results of Operations of our 2008 Form 10-K. For more
information regarding our current contingencies and commitments, see Note 8 to the financial
statements included above, which is incorporated by reference herein.
Material Changes in Financial Condition
June 30, | December 31, | |||||||
(In thousands) | 2009 | 2008 | ||||||
$ | $ | |||||||
Total assets |
7,383 | 14,790 | ||||||
Total liabilities |
3,445 | 4,083 | ||||||
Shareholders equity |
3,938 | 10,707 |
The decrease in assets from December 31, 2008 primarily relates to decreased cash, cash equivalents
and marketable securities as these assets have been used to fund operations. The decrease in
liabilities from December 31, 2008 relates predominantly to the payment in 2009 of significant
manufacturing costs included in Accounts Payable at year end.
Critical Accounting Policies and Estimates
The preparation of financial statements in accordance with GAAP requires management to make
estimates and assumptions that affect reported amounts and related disclosures. We have discussed
those estimates that we believe are critical and require the use of complex judgment in their
application in our 2008 Form 10-K. Since the date of our 2008 Form 10-K, there have been no
material changes to our critical accounting policies or the methodologies or assumptions we apply
under them.
New Accounting Standards
See Note 3, Accounting Policies, of the consolidated financial statements for information related
to the adoption of new accounting standards in 2009, none of which had a material impact on our
financial statements, and the future adoption of recently issued accounting standards, which we do
not expect to have a material impact on our financial statements.
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Item 3. | Quantitative and Qualitative Disclosures About Market Risk |
Interest Rate Risk
We invest our cash in a variety of financial instruments, primarily in short-term bank deposits,
money market funds, and domestic and foreign commercial paper and government securities. These
investments are denominated in U.S. dollars and are subject to interest rate risk, and could
decline in value if interest rates fluctuate. Our investment portfolio includes only marketable
securities with active secondary or resale markets to help ensure portfolio liquidity. Due to the
conservative nature of these instruments, we do not believe that we have a material exposure to
interest rate risk. For example, if market rates hypothetically increase immediately and uniformly
by 100 basis points from levels at June 30, 2009, the decline in the fair value of our investment
portfolio would not be material.
Foreign Currency Exchange Risk
We are exposed to risks associated with foreign currency transactions on certain contracts and
payroll expenses related to our Canadian subsidiary, OncoGenex Technologies, denominated in
Canadian dollars and we have not hedged these amounts. As our unhedged foreign currency
transactions fluctuate, our earnings might be negatively affected. Accordingly, changes in the
value of the U.S. dollar relative to the Canadian dollar might have an adverse effect on our
reported results of operations and financial condition, and fluctuations in exchange rates might
harm our reported results and accounts from period to period.
Item 4. | Controls and Procedures |
Evaluation of Disclosure Controls and Procedures
The Company maintains disclosure controls and procedures that are designed to ensure that material
information required to be disclosed in the Companys periodic reports filed or submitted under the
Securities Exchange Act of 1934, as amended (the Exchange Act), is recorded, processed,
summarized and reported within the time periods specified in the SECs rules and forms. The
Companys disclosure controls and procedures are also designed to ensure that information required
to be disclosed in the reports the Company files or submits under the Exchange Act is accumulated
and communicated to the Companys management, including its principal executive officer and
principal financial officer as appropriate, to allow timely decisions regarding required
disclosure.
During the quarter ended June 30, 2009 the Company carried out an evaluation, under the supervision
and with the participation of the Companys management, including the chief executive officer and
the chief financial officer, of the effectiveness of the design and operation of the disclosure
controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based
upon that evaluation, the Companys chief executive officer and chief financial officer concluded
that the Companys disclosure controls and procedures were effective, as of the end of the period
covered by this report.
Changes in Internal Control Over Financial Reporting
The Company has not made any changes to our internal control over financial reporting (as defined
in Rule 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended June 30, 2009 that
have materially affected, or are reasonably likely to materially affect, the Companys internal
control over financial reporting.
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PART II. OTHER INFORMATION
Item 1A. | Risk Factors |
In addition to the other information set forth in this Quarterly Report on Form 10-Q, you should
carefully consider the factors discussed in Part I, Item 1A. Risk Factors, in our Annual Report on
Form 10-K for the year ended December 31, 2008, as filed with the SEC on March 11, 2009, which
could materially affect our business, financial condition or future results. There have been no
material changes to the risk factors described in that report.
Item 4. | Submission of Matters to a Vote of Security Holders |
Our Annual Meeting of Stockholders was held on May 12, 2009. At the Annual Meeting, two matters
were submitted to a vote of security holders.
Each director nominated and the other proposal submitted to a vote passed and the voting outcome of
each proposal was as follows:
1. Election of the following six (6) directors to serve until the next Annual Meeting of
Stockholders or until their successors are elected and have qualified to serve as directors:
Nominee | For | Withheld | ||||||
Patrick R. Brady |
3,456,247 | 75,189 | ||||||
Michelle G. Burris |
3,449,858 | 81,578 | ||||||
Neil Clendeninn |
3,449,586 | 81,850 | ||||||
Scott Cormack |
3,461,508 | 69,928 | ||||||
Michael A. Martino |
2,430,405 | 1,101,031 | ||||||
Dwight Winstead |
3,448,590 | 82,846 |
2. Ratification of the appointment of Ernst & Young LLP as the Companys independent auditor for
the fiscal year ending December 31, 2009:
For: 3,522,136
|
Against: 5,048 | Abstain: 4,251 |
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Item 6. | Exhibits |
Exhibit | ||||
Number | Description | |||
2.1 | (1) | Arrangement Agreement between the Company and OncoGenex Technologies Inc. dated May 27, 2008 |
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2.2 | (2) | First Amendment to Arrangement Agreement between the Company and OncoGenex Technologies Inc. dated August 11, 2008 |
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2.3 | (2) | Second Amendment to Arrangement Agreement between the Company and OncoGenex Technologies Inc. dated August 15, 2008 |
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3.1 | (3) | Amended and Restated Certificate of Incorporation (As Amended Through October 17, 1995) |
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3.2 | (4) | Certificate of Amendment to Certificate of Incorporation filed on May 6, 1999 |
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3.3 | (5) | Certificate of Correction filed on March 9, 2009 to Certificate of Amendment filed on May 6, 1999 |
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3.4 | (6) | Certificate of Amendment to Certificate of Incorporation filed on May 7, 2004 |
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3.5 | (5) | Certificate of Correction filed on March 9, 2009 to Certificate of Amendment filed on May 7, 2004 |
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3.6 | (2) | Certificate of Amendment to Certificate of Incorporation filed on August 20, 2008 |
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3.7 | (7) | Third Amended and Restated Bylaws of Oncogenex Pharmaceuticals, Inc. |
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4.1 | (2) | Specimen Certificate of Common Stock |
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4.2 | (8) | Amended and Restated Rights Agreement dated as of July 24, 2002 between the Company and U.S. Stock Transfer Corporation |
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4.3 | (9) | First Amendment to Amended and Restated Rights Agreement dated as of October 17, 2005 between the Company and U.S. Stock Transfer Corporation |
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4.4 | (10) | Second Amendment to Amended and Restated Rights Agreement dated as of August 10, 2006 between the Company and U.S. Stock Transfer Corporation |
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4.5 | (11) | Third Amendment to Amended and Restated Rights Agreement dated May 27, 2008 between the Company and Computershare Trust Company, N.A. |
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4.6 | (1) | Form of Escrow Agreement between the Company, Computershare Trust Company of Canada and former shareholders and debentureholders of OncoGenex Technologies Inc. |
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4.7 | (1) | Form of OncoGenex Voting Agreement |
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4.8 | (1) | Form of Sonus Voting Agreement |
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10.1 | (12) | Sonus Pharmaceuticals, Inc. Incentive Stock Option, Nonqualified Stock Option and Restricted Stock Purchase Plan 1991 (the 1991 Plan), as amended |
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10.2 | (12) | Form of Incentive Option Agreement (pertaining to the 1991 Plan) |
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10.3 | (12) | Form of Sonus Pharmaceuticals, Inc. Nonqualified Stock Option Agreement under the 1991 Plan |
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10.4 | (13) | Sonus Pharmaceuticals, Inc. 1999 Nonqualified Stock Incentive Plan (the 1999 Plan) |
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10.5 | (13) | Form of Sonus Pharmaceuticals, Inc. Nonqualified Stock Option Agreement under the 1999 Plan |
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10.6 | (13) | Form of Sonus Pharmaceuticals, Inc. Restricted Stock Purchase Agreement under the 1999 Plan |
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10.7 | (14) | Sonus Pharmaceuticals, Inc. 2000 Stock Incentive Plan (the 2000 Plan) |
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10.8 | (15) | First Amendment to Sonus Pharmaceuticals, Inc. 2000 Plan |
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10.9 | (14) | Form of Sonus Pharmaceuticals, Inc. Stock Option Agreement (pertaining to the 2000 Plan) |
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10.10 | (16) | Sonus Pharmaceuticals, Inc. 2007 Performance Incentive Plan (the 2007 Plan) |
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10.11 | (17) | Form of Sonus Pharmaceuticals, Inc. Stock Option Agreement (pertaining to the 2007 Plan) |
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Exhibit | ||||
Number | Description | |||
10.12 | (17) | Form of Sonus Pharmaceuticals, Inc. Restricted Stock Purchase Agreement under the 2007 Plan |
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10.13 | (18) | OncoGenex Technologies Inc. Amended and Restated Stock Option Plan |
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10.14 | (19) | Stock Option Assumption, Amending and Confirmation Agreement dated as of August 21, 2008 between the Company and OncoGenex Technologies Inc. |
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10.15 | (20) | OncoGenex Pharmaceuticals, Inc. Short Term Incentive Awards Program |
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10.16 | (20) | Agreement and Consent Form (related to the Short Term Incentive Awards Program) |
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10.17 | (20) | Director Compensation Policy |
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10.18 | (12) | Form of Indemnification Agreement for Officers and Directors of the Company |
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10.19 | (18) | Form of Indemnification Agreement between OncoGenex Technologies Inc. and each of Scott Cormack, Stephen Anderson and Cindy Jacobs |
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10.20 | (18) | Form of Indemnification Agreement between OncoGenex Technologies Inc. and Neil Clendeninn |
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10.21 | (21) | Severance/Change in Control Agreement dated January 11, 2008 between the Company and Michael Martino |
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10.22 | (2) | Executive Termination Agreement and General Release dated August 21, 2008 between the Company and Michael Martino |
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10.23 | (21) | Severance/Change in Control Agreement dated January 11, 2008 between the Company and Alan Fuhrman |
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10.24 | (2) | Executive Termination Agreement and General Release dated August 21, 2008 between the Company and Alan Fuhrman |
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10.25 | (18) | Employment Agreement between OncoGenex Technologies Inc. and Scott Cormack dated as of December 21, 2001, and Employment Amending Agreement dated as of August
10, 2005 |
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10.26 | (22) | Employment Agreement between OncoGenex Technologies Inc. and Stephen Anderson dated as of January 9, 2006* |
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10.27 | (2) | Employment Amending Agreement dated June 28, 2007 between OncoGenex Technologies Inc. and Stephen Anderson |
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10.28 | (22) | Employment Agreement between OncoGenex, Inc. and Cindy Jacobs dated as of September 12, 2005* |
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10.29 | (23) | Securities Purchase Agreement dated as of August 15, 2005 by and among the Company and the investors named therein, together with their permitted transferees
(Securities Purchase Agreement) |
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10.30 | (23) | Form of Purchase Warrant related to the Securities Purchase Agreement |
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10.31 | (24) | Form of Purchase Warrant issued to Schering AG |
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10.32 | (23) | Registration Rights Agreement dated as of August 15, 2005 by and among the Company and the investors named therein |
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10.33 | (25) | Lease by and between BMR-217th Place LLC and the Company dated as of November 21, 2006 |
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10.34 | (26) | First Amendment to Lease by and between BMR-217th Place LLC and the Company dated as of August 17, 2007 |
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10.35 | (27) | Second Amendment to Lease by and between BMR-217th Place LLC and the Company dated as of January 28, 2008 |
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10.36 | (6) | Amended and Restated License Agreement effective as of July 2, 2008 by and between OncoGenex Technologies Inc. and Isis Pharmaceuticals, Inc. (OGX-011)* |
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10.37 | (22) | License Agreement between OncoGenex Technologies Inc. and the University of British Columbia effective as of November 1, 2001, and Amending Agreement dated as
of August 30, 2006 (OGX-011)* |
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Exhibit | ||||
Number | Description | |||
10.38 | (2) | Second Amending Agreement and Consent as of August 7, 2008 between The University of British Columbia and OncoGenex Technologies Inc. (OGX-011) |
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10.39 | (22) | Collaboration and License Agreement between OncoGenex Technologies Inc. and Isis Pharmaceuticals, Inc. effective as of January 5, 2005 (OGX-427)* |
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10.40 | (22) | License Agreement between OncoGenex Technologies Inc. and the University of British Columbia effective as of April 5, 2005, and Amending Agreement dated as of
August 30, 2006 (OGX-427)* |
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10.41 | (2) | Second Amending Agreement as of August 7, 2008 between The University of British Columbia and OncoGenex Technologies Inc. (OGX-427) |
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31.1 | Certification of President and Chief Executive Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002 |
|||
31.2 | Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002 |
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32.1 | Certification of President and Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|||
32.2 | Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
| Schedules and similar attachments to the Arrangement Agreement have been omitted pursuant to Item 601(b)(2) of Regulation S-K. Registrant will furnish supplementally a copy of any omitted schedule or similar attachment to the SEC upon request. | |
* | Confidential portions of this exhibit have been omitted and filed separately with the Commission pursuant to an application for Confidential Treatment under Rule 24b-2 promulgated under the Securities Exchange Act of 1934, as amended. | |
(1) | Incorporated by reference to the Companys proxy statement on Schedule 14A filed on July 3, 2008. | |
(2) | Incorporated by reference to the Companys quarterly report on Form 10-Q for the quarter ended September 30, 2008. | |
(3) | Incorporated by reference to the Companys Registration Statement on Form S-1, Reg. No. 33-96112. | |
(4) | Incorporated by reference to Companys quarterly report on Form 10-Q for the quarter ended March 31, 1999. | |
(5) | Incorporated by reference to the Companys current report on Form 8-K filed on March 11, 2009. | |
(6) | Incorporated by reference to the Companys annual report on Form 10-K for the year ended December 31, 2008. | |
(7) | Incorporated by reference to the Companys current report on Form 8-Kfiled on October 30, 2008. | |
(8) | Incorporated by reference to the Companys amended Form 8-A filed on July 25, 2002. | |
(9) | Incorporated by reference to the Companys amended Form 8-A filed on October 18, 2005. | |
(10) | Incorporated by reference to the Companys amended Form 8-A filed on August 14, 2006. | |
(11) | Incorporated by reference to the Companys current report on Form 8-K filed on May 30, 2008. | |
(12) | Incorporated by reference to the Companys registration statement on Form S-1, Reg. No. 33-96112. | |
(13) | Incorporated by reference to the Companys quarterly report on Form 10-Q for the quarter ended March 31, 1999. | |
(14) | Incorporated by reference to the Companys quarterly report on Form 10-Q for the quarter ended June 30, 2000. |
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(15) | Incorporated by reference to the Companys quarterly report on Form 10-Q for the quarter ended September 30, 2006. | |
(16) | Incorporated by reference to the Companys proxy statement on Schedule 14A filed on April 3, 2007. | |
(17) | Incorporated by reference to the Companys quarterly report on Form 10-Q for the quarter ended September 30, 2007. | |
(18) | Incorporated by reference to the OncoGenex Technologies Inc. registration statement on Form F-1 filed on December 13, 2006. | |
(19) | Incorporated by reference to the Companys registration statement on Form S-8 filed on August 26, 2008. | |
(20) | Incorporated by reference to the Companys current report on Form 8-K filed on April 2, 2009. | |
(21) | Incorporated by reference to the Companys current report on Form 8-K filed on January 17, 2008. | |
(22) | Incorporated by reference to the OncoGenex Technologies Inc. registration statement on Form F-1, Amendment No. 1, filed on January 29, 2007. | |
(23) | Incorporated by reference to the Companys current report on Form 8-K filed on August 18, 2005. | |
(24) | Incorporated by reference to the Schedule 13D filed by Schering Berlin Venture Corporation on October 31, 2005. | |
(25) | Incorporated by reference to the Companys annual report on Form 10-K for the year ended December 31, 2006. | |
(26) | Incorporated by reference to the Companys annual report on Form 10-K for the year ended December 31, 2007. | |
(27) | Incorporated by reference to the Companys quarterly report on Form 10-Q for the quarter ended March 31, 2008. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned, thereunto duly authorized.
ONCOGENEX PHARMACEUTICALS, INC. |
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Date: August 6, 2009 | By: | /s/ Stephen Anderson | ||
Stephen Anderson | ||||
Chief Financial Officer and Secretary (Principal Financial and Accounting Officer) |
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EXHIBIT INDEX
Exhibit | ||||
Number | Description | |||
31.1 | Certification of President and Chief Executive Officer
pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities
Exchange Act of 1934, as adopted pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002 |
|||
31.2 | Certification of Chief Financial Officer pursuant to Rule
13a-14(a) or 15d-14(a) of the Securities Exchange Act of
1934, as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002 |
|||
32.1 | Certification of President and Chief Executive Officer
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002 |
|||
32.2 | Certification of Chief Financial Officer pursuant to 18
U.S.C. Section 1350, as adopted pursuant to Section 906 of
the Sarbanes-Oxley Act of 2002 |
38