UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
FORM 10-Q
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2009
or
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o |
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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)
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Delaware
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95-4343413 |
(State or Other Jurisdiction of
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(I.R.S. Employer Identification Number) |
Incorporation or Organization) |
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1522 217 th Place SE, Suite 100, Bothell, Washington 98021
(Address of Principal Executive Offices)
(425) 686-1500
(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.
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Large accelerated filer o
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Accelerated filer o
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Non-accelerated filer o
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Smaller reporting company þ |
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(Do not check if a smaller reporting company) |
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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.
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Class
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Outstanding at November 1, 2009 |
Common Stock, $0.001 par value
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6,034,959 |
OncoGenex Pharmaceuticals, Inc.
Index to Form 10-Q
2
PART I. FINANCIAL INFORMATION
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Item 1. |
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Consolidated Financial Statements |
OncoGenex Pharmaceuticals, Inc.
Consolidated Balance Sheets
(Unaudited)
(a development stage enterprise)
(In thousands of U.S. dollars)
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September 30, |
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December 31, |
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2009 |
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2008 |
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$ |
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$ |
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Note 1 |
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ASSETS |
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Current |
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Cash and cash equivalents |
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10,053 |
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7,618 |
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Short-term investments [Note 4] |
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2,420 |
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4,801 |
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Amounts receivable |
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31 |
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153 |
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Investment tax credit recoverable |
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1,090 |
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Prepaid expenses |
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753 |
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587 |
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Other current assets |
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734 |
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Total current assets |
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13,991 |
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14,249 |
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Property and equipment, net |
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84 |
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44 |
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Other assets |
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509 |
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497 |
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Total assets |
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14,584 |
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14,790 |
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LIABILITIES AND SHAREHOLDERS EQUITY |
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Current |
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Accounts payable and accrued liabilities |
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1,851 |
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2,252 |
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Current portion of long-term obligations [Note 6] |
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457 |
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632 |
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Total current liabilities |
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2,308 |
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2,884 |
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Long-term obligation, less current portion [Note 6] |
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1,268 |
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1,199 |
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Total liabilities |
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3,576 |
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4,083 |
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Commitments and contingencies [Note 8] |
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Common Shares: |
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$0.001 par value 11,019,930 shares authorized and 6,034,959 issued and
outstanding at September 30, 2009 and 5,544,114 issued and outstanding at December 31, 2008 |
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6 |
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6 |
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Additional paid-in capital |
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65,727 |
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56,070 |
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Deficit accumulated during the development stage |
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(57,367 |
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(48,009 |
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Accumulated other comprehensive income |
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2,642 |
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2,640 |
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Total shareholders equity |
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11,008 |
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10,707 |
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Total liabilities and shareholders equity |
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14,584 |
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14,790 |
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Subsequent Events [Note 11]
See accompanying notes.
3
OncoGenex Pharmaceuticals, Inc.
Consolidated Statements of Operations
(Unaudited)
(In thousands of U.S. dollars, except per share and share amounts)
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Period from |
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26-May-00 |
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Three months |
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Nine months |
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(inception) |
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Ended September 30, |
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Ended September 30, |
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to September 30, |
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2009 |
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2008 |
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2009 |
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2008 |
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2009 |
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$ |
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$ |
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$ |
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$ |
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$ |
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EXPENSES |
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Research and development |
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1,513 |
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1,639 |
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6,795 |
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3,621 |
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35,403 |
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General and administrative |
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885 |
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1,024 |
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2,670 |
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2,243 |
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16,092 |
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Total expenses |
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2,398 |
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2,663 |
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9,465 |
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5,864 |
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51,495 |
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OTHER INCOME (EXPENSE) |
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Interest income |
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5 |
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51 |
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41 |
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142 |
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1,453 |
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Other |
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24 |
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246 |
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79 |
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(54 |
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(504 |
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Total other income (expense) |
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29 |
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297 |
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120 |
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88 |
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949 |
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Loss for the period before taxes and extraordinary gain |
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2,369 |
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2,366 |
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9,345 |
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5,776 |
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50,546 |
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Income tax expense (recovery) |
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16 |
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(2,515 |
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12 |
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(2,100 |
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120 |
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Loss (income) before extraordinary gain |
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2,385 |
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(149 |
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9,357 |
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3,676 |
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50,666 |
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Extraordinary gain [Note 2] |
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4,428 |
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4,428 |
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4,428 |
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Net loss (income) |
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2,385 |
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(4,577 |
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9,357 |
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(752 |
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46,238 |
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Redeemable convertible preferred share accretion |
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417 |
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1,973 |
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11,129 |
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Loss (income) attributable to common shareholders |
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2,385 |
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(4,160 |
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9,357 |
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1,221 |
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57,367 |
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Basic and diluted loss (income) per common share
[Note 5[e]] |
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0.40 |
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(2.02 |
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1.65 |
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1.59 |
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Weighted average number of common shares [Note 5[e]] |
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5,906,059 |
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2,056,876 |
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5,671,158 |
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769,843 |
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See accompanying notes.
4
OncoGenex Pharmaceuticals, Inc.
Consolidated Statements of Cash Flows
(Unaudited)
(In thousands of U.S. dollars)
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Period from |
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26-May-00 |
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Nine months ended |
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(inception) to |
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September 30, |
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September 30, |
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2009 |
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2008 |
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2009 |
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$ |
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$ |
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$ |
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OPERATING ACTIVITIES |
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Loss for the period |
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(9,357 |
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752 |
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(46,238 |
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Add items not involving cash |
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Extraordinary gain |
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(4,428 |
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(4,428 |
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Depreciation and amortization |
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38 |
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49 |
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465 |
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Stock-based collaboration expense |
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1,758 |
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Stock-based compensation [Note 5[c]] |
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290 |
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144 |
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1,025 |
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Accrued interest on convertible debenture |
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319 |
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505 |
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Changes in non-cash working capital items |
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Amounts receivable |
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122 |
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197 |
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249 |
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Investment tax credit recoverable |
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1,090 |
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521 |
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Prepaid expenses |
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(166 |
) |
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75 |
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(461 |
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Other assets |
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(746 |
) |
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(734 |
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(875 |
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Accounts payable and accrued liabilities |
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(401 |
) |
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(1,797 |
) |
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(1,599 |
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Lease obligation |
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(106 |
) |
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(17 |
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(359 |
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Taxes payable on preferred shares |
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(2,487 |
) |
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Cash used in operating activities |
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(9,236 |
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(7,406 |
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(49,958 |
) |
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FINANCING ACTIVITIES |
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Cash paid on fractional shares eliminated on reverse share split |
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(3 |
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(3 |
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Proceeds from issuance of common stock under stock option and employee purchase plans |
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67 |
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6 |
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191 |
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Issuance of preferred shares, net of share issue costs |
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26,719 |
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Issuance of common shares, net of share issue costs |
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9,303 |
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9,449 |
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Issuance of convertible debentures net of issue costs |
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4,442 |
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Cash provided by financing activities |
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9,370 |
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3 |
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40,798 |
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5
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Period from |
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26-May-00 |
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Nine months ended |
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(inception) to |
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September 30, |
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September 30, |
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2009 |
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2008 |
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2009 |
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$ |
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$ |
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$ |
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INVESTING ACTIVITIES |
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Purchase of investments |
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(3,933 |
) |
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(4,343 |
) |
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(92,953 |
) |
Proceeds from sale of investments |
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6,280 |
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8,473 |
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107,864 |
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Purchase of property and equipment |
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(15 |
) |
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(4 |
) |
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(406 |
) |
Cash received on reverse takeover of Sonus |
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5,464 |
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5,464 |
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Transaction fees on reverse takeover of Sonus |
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(807 |
) |
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(807 |
) |
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Cash provided by investing activities |
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2,332 |
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8,783 |
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19,162 |
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Effect of exchange rate changes on cash and cash equivalents |
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(31 |
) |
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42 |
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|
51 |
|
Increase (decrease) in cash and cash equivalents during the period |
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2,435 |
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|
1,422 |
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|
10,053 |
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Cash and cash equivalents, beginning of the period |
|
|
7,618 |
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|
4,626 |
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Cash and cash equivalents, end of the period |
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10,053 |
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6,048 |
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10,053 |
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Supplemental cash flow information |
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Property and equipment acquired under lease obligation |
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65 |
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65 |
|
See accompanying notes.
6
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 castrate
resistant prostate cancer (CRPC). We are seeking 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. We may also seek additional funding
through 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
nine month periods ended September 30, 2009. The consolidated results of operations of the Company
include the results of operations of OncoGenex Technologies for the full three and nine month
periods ended September 30, 2008 and the results of OncoGenex Pharmaceuticals, Inc. following the
completion of the Arrangement.
7
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 Arrangement 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 Technologies |
|
|
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 |
|
8
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.
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 the Companys 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 nine |
|
|
|
months ended |
|
|
|
September 30, |
|
(In thousands, except shares and loss per share) |
|
2008 |
|
|
|
$ |
Revenue |
|
$ |
|
|
Net loss applicable to common shareholders |
|
$ |
(21,241 |
) |
Net loss per share-basic and diluted |
|
$ |
(27.59 |
) |
Weighted average shares |
|
|
769,843 |
|
3. ACCOUNTING POLICIES
Recently Adopted Accounting Policies
In November 2007, the Emerging Issues Task Force (EITF) issued Accounting Standards Codification
(ASC) 808, Collaborative Arrangements. ASC 808 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, ASC 808 clarified that the determination of whether transactions within a collaborative
arrangement are part of a vendor-customer (or analogous) relationship. ASC 808 is effective for
fiscal years beginning after December 15, 2008 and was adopted by the Company on January 1, 2009.
The adoption of ASC 808 did not have a material impact on the consolidated financial position,
results of operations or cash flows.
9
In December 2007, the Financial Accounting Standards Board (FASB) issued ASC 805, Business
Combinations. ASC 805 changed the accounting treatment and disclosure for certain specific items
in a
business combination. Under ASC 805, an acquiring entity is required to recognize all the assets
acquired and liabilities assumed in a transaction at the acquisition-date fair value with limited
exceptions. ASC 805 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 ASC 805 has not had a material impact on the Companys
consolidated financial position, results of operations or cash flows.
In December 2007, the FASB made amendments to ASC 810-10, Consolidation, which establishes new
accounting and reporting standards for the noncontrolling interest in a subsidiary and for the
deconsolidation of a subsidiary. ASC 810-10 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 ASC 810-10 has
not had a material impact on the Companys consolidated financial position, results of operations
or cash flows.
In March 2008, the FASB issued amendments to ASC 815-10, Derivatives and Hedging. ASC 815-10
amends and expands the disclosure requirements 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 amendments to ASC 815-10-65 to require disclosures by sellers of
credit derivatives, including credit derivatives embedded in a hybrid instrument and requires an
additional disclosure about the current status of the payment/performance risk of a guarantee. 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 amendments to ASC 350-30, Intangibles Goodwill and Other which
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 ASC 350, and also requires
expanded disclosure regarding the determination of intangible asset useful lives. The amendments to
ASC 350-30 are effective for fiscal years beginning after December 15, 2008 and were adopted by the
Company on January 1, 2009. The adoption of these amendments has not had a material impact on the
Companys consolidated financial position, results of operations or cash flows.
In May 2008, the FASB issued amendments to ASC 470-20, Debt. The amendments 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. The amendments to ASC 470-20 were adopted by the
Company on January 1, 2009. The adoption of amendments to ASC 470-20 have not had a material impact
on the Companys consolidated financial position, results of operations, cash flows or earnings per
share.
In June 2008, the FASB issued amendments to ASC 260-10, Earnings Per Share. The amendments to ASC
260-10 address 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. Under the amendments to ASC 260-10,
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. The amendments to ASC 260-10
are effective for fiscal years beginning after December 15, 2008 and were adopted by the Company on
January 1, 2009. All prior-period earnings per share amounts presented shall be adjusted
retrospectively. The adoption of the amendments to ASC 260-10 has not had a material impact on the
consolidated financial position, results of operations or cash flows.
10
In June 2008, the FASB ratified the amendments to ASC 815-40, Derivatives and Hedging. The
amendments to ASC 815-40 provide guidance for determining whether an equity-linked financial
instrument (or embedded feature) is indexed to an entitys own stock. ASC 815-40 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 ASC 718, Compensation Stock
Compensation). 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. The amendments to ASC 815-40 are effective for fiscal years beginning after
December 15, 2008 and were adopted by the Company on January 1, 2009. The adoption of the
amendments to ASC 815-40 has not resulted in a material change to the classification or measurement
of its financial instruments.
In December 2008, the EITF issued amendments to ASC 350-30, Intangibles Goodwill and Other.
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. The amendments to ASC 350-30 require 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 the amendments to ASC 350-30 on January 1,
2009. The adoption of the amendments to ASC 350-30 has not had a material impact on the
consolidated financial position, results of operations or cash flows.
In April 2009, the FASB issued amendments to ASC 805-20, Business Combinations. These amendments
clarify ASC 805-20 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 ASC 450, Contingencies, to determine
whether the contingency should be recognized at the acquisition date or after it. The amendments to
ASC 805-20 are 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 the amendments to ASC
805-20 effective January 1, 2009. The adoption of the amendments to ASC 805-20 has not had a
material impact on the consolidated financial position, results of operations or cash flows.
In April 2009, the FASB issued amendments to ASC 320-10, Investment Debt and Equity Securities,
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. The amendments to ASC
320-10 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 the amendments to ASC 320-10 has not
had a material impact on the consolidated financial position, results of operations or cash flows.
In April 2009, the FASB issued amendments to ASC 825-10, Financial Instruments, which require
fair value disclosures for financial instruments that are not reflected in the consolidated Balance
Sheets at fair value. Prior to the issuance these amendments to ASC 825-10, the fair values of
those assets and liabilities were disclosed only once each year. With the issuance the amendments
to ASC 825-10, 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. The amendments to ASC 825-10 become effective for interim reporting periods that end
after June 15, 2009, and were adopted in our second quarter of 2009. The adoption of the amendments
to ASC 825-10 has not had a material impact on the consolidated financial position, results of
operations or cash flows.
11
In April 2009, the FASB issued amendments to ASC 820-10, Fair Value Measurement and Disclosure,
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. The amendments to ASC 820-10 also
reaffirm the objective of fair value measurement, which is to reflect how much an asset would be
sold for in an orderly transaction. They also reaffirm 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. The amendments to ASC 820-10 which are 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 the amendments to ASC 820-10 has not had a material impact on the
consolidated financial position, results of operations or cash flows.
In May 2009, the FASB issued ASC 855, Subsequent Events. ASC 855 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. ASC 855 is effective for interim reporting periods ending after June 15, 2009, and
was adopted in our second quarter of 2009. In accordance with ASC 855 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 ASC 855 has not had a material impact on the consolidated financial
position, results of operations or cash flows.
In June 2009, the FASB issued ASC 105, Generally Accepted Accounting Principles. ASC 105
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 ASC 105 and the
Codification does not change GAAP. ASC 105 became effective for the Company for the period ending
September 30, 2009. The adoption of ASC 105 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 amendments to ASC 810-10, Consolidation 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. These amendments to ASC 810-10 become effective for the Company on January 1,
2010. The Company does not expect that the adoption of the amendments to ASC 810-10 to have a
material effect on its consolidated financial statements or disclosures.
12
In June 2009, the FASB issued amendments to ASC 860-10, Transfers and Servicing. The amendments
to ASC 860-10 remove the concept of a qualifying special-purpose entity and removes the exception
from applying ASC 810-10 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. The amendments to ASC
860-10 become effective for the Company on January 1, 2010. The Company does not expect that the
adoption of the amendments to ASC 860-10 to have a material effect on its consolidated financial
statements or disclosures.
4. FAIR VALUE MEASUREMENTS
With the adoption of ASC 820 Fair Value Measurements and Disclosures, 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.
ASC 820 specifies a hierarchy of valuation techniques based on whether the inputs to those
valuation techniques are observable or unobservable. In accordance with ASC 820, 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 ASC 820.
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.
13
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 September 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 |
|
$ |
|
|
|
$ |
3,420 |
|
|
$ |
|
|
Corporate bonds and commercial paper |
|
$ |
|
|
|
$ |
2,500 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
5,920 |
|
|
|
|
|
Marketable securities as at September 30, 2009 consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortized |
|
|
Gross Unrealized |
|
|
Gross Unrealized |
|
|
Estimated |
|
(In thousands) |
|
Cost |
|
|
Gain |
|
|
Loss |
|
|
Fair Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Government debt securities |
|
$ |
3,418 |
|
|
$ |
2 |
|
|
$ |
|
|
|
$ |
3,420 |
|
Corporate bonds and commercial paper |
|
$ |
2,500 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
2,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
5,918 |
|
|
$ |
2 |
|
|
$ |
|
|
|
$ |
5,920 |
|
$2,500,000 of Commercial paper and $1,000,000 of Government debt securities 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.
14
There were no significant realized or unrealized gains or losses on the sales of marketable
securities in the nine month periods ended September 30, 2009 or September 30, 2008, and no
significant unrealized gains or losses are included in accumulated other comprehensive income as at
September 30, 2009. Realized gains and losses are transferred out of accumulated other
comprehensive income into interest income using the specific identification method.
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 nine month period ended September 30, 2009 the Company issued 15,845 common shares upon
exercise of stock options (period ended September 30, 2008 4,352). The Company issues new common
shares to satisfy stock option exercises.
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 by the SEC on
July 17, 2009. The transaction provided net proceeds of approximately $9.3 million after deducting
costs associated with the offering.
[c] Stock options
Stock Option Summary
As at September 30, 2009 the Company has reserved, pursuant to various plans, 878,098 common shares
for issuance upon exercise of stock options by employees, directors, officers and consultants of
the Company of which 138,654 are not currently subject to outstanding grants and are
available for future grants.
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 |
|
|
(15,845 |
) |
|
|
4.08 |
|
Option expirations |
|
|
(1,240 |
) |
|
|
3.89 |
|
Option forfeitures |
|
|
(1,000 |
) |
|
|
3.00 |
|
|
|
|
|
|
|
|
|
|
Balance, September 30, 2009 |
|
|
739,444 |
|
|
|
5.01 |
|
15
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 ASC 718 Compensation Stock Compensation, 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 |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Research and development |
|
|
22 |
|
|
|
20 |
|
|
|
67 |
|
|
|
61 |
|
General and administrative |
|
|
95 |
|
|
|
15 |
|
|
|
223 |
|
|
|
83 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total share-based compensation |
|
|
117 |
|
|
|
35 |
|
|
|
290 |
|
|
|
144 |
|
As at September 30, 2009 and December 31, 2008 the total unrecognized compensation expense
related to stock options granted is $618,396 and $740,000 respectively, which is expected to be
recognized into expense over a period of approximately four years.
[d] Stock Warrants
At September 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.
16
[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 Arrangement.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
(In thousands except shares and per share amounts) |
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
|
|
Numerator |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss (income) attributable to common shareholders
as reported |
|
$ |
2,385 |
|
|
$ |
(4,160 |
) |
|
$ |
9,357 |
|
|
$ |
1,221 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding |
|
|
5,906,059 |
|
|
|
2,056,876 |
|
|
|
5,671,158 |
|
|
|
769,843 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per common share |
|
$ |
0.40 |
|
|
$ |
2.02 |
|
|
$ |
1.65 |
|
|
$ |
(1.59 |
) |
Earnings per share associated with $4,428,000
extraordinary gain |
|
|
|
|
|
|
2.15 |
|
|
|
|
|
|
|
5.75 |
|
Basic and diluted income (loss) per common
share excluding
extraordinary gain |
|
$ |
0.40 |
|
|
$ |
(0.13 |
) |
|
$ |
1.65 |
|
|
$ |
(7.34 |
) |
As of September 30, 2009 and December 31, 2008 a total of 922,829 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 September 30, 2009 and
December 31, 2008 was nil.
On August 21, 2008, immediately following the completion of the Arrangement (Note 2), the Company
reduced its workforce by approximately 49%. 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 expects that all
remaining severance liabilities relating to transaction-related workforce reductions will be paid
out in November 2009, and the amount owing at September 30, 2009 was $3,000.
17
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 the Company revised its 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 the excess lease liability and a $494,000 research and development 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 nine month periods ended September 30, 2009. The estimated fair value of
the liability remaining at September
30, 2009 with respect to excess facilities is $1,386,000.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liability |
|
|
|
Remaining |
|
|
|
|
|
|
Amortization |
|
|
Additional |
|
|
at |
|
|
|
Liability at |
|
|
Payments |
|
|
of excess |
|
|
Liability |
|
|
September |
|
(In thousands) |
|
31-Dec-08 |
|
|
made |
|
|
lease facility |
|
|
Recorded |
|
|
30, 2009 |
|
Employee severance included in accrued liabilities |
|
$ |
137 |
|
|
$ |
134 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
3 |
|
Current portion of excess lease facility |
|
$ |
632 |
|
|
$ |
|
|
|
$ |
(714 |
) |
|
$ |
508 |
|
|
$ |
426 |
|
Long-term portion of excess lease facility |
|
$ |
1,090 |
|
|
$ |
|
|
|
|
(116 |
) |
|
$ |
(14 |
) |
|
$ |
960 |
|
7. TAXES
Under ASC 740, Income Taxes, 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 nine months
ended September 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 |
|
|
149 |
|
Deductions based on tax positions related to the current year |
|
|
(365 |
) |
|
|
|
|
Balance as of September 30, 2009 |
|
|
1,740 |
|
As of September 30, 2009 unrecognized benefits of approximately $1,740,000, if recognized, would
affect the Companys effective tax rate.
18
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 which
is included in research and development expense.
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 and included in research and development expense. 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 million 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.
19
Future minimum annual lease payments under the Vancouver lease are as follows:
|
|
|
|
|
|
|
$ |
|
|
|
(In thousands) |
|
2009 |
|
|
44 |
|
2010 |
|
|
177 |
|
2011 |
|
|
44 |
|
|
|
|
|
|
|
|
|
|
Total |
|
|
265 |
|
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. 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 $1,386,000 as at September 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 |
|
|
485 |
|
2010 |
|
|
1,995 |
|
2011 |
|
|
2,055 |
|
2012 |
|
|
2,117 |
|
2013 |
|
|
2,180 |
|
remainder |
|
|
9,395 |
|
|
|
|
|
|
|
|
|
|
Total |
|
|
18,227 |
|
Consolidated rent expense for the nine month periods ended September 30, 2009 and 2008 was
$1,757,000 and $436,000 respectively.
Other Purchase Commitments
As of September 30, 2009, the Company has entered into purchase commitments totalling $1,390,000 to
purchase OGX-011 drug product, which we expect to incur in the fourth quarter of 2009.
Guarantees and Indemnifications
ASC 460 Guarantees 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
September 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.
20
9. RELATED PARTY TRANSACTIONS
The Company incurred consulting fees of $74,000 for the nine month period ended September 30, 2008
payable to a former director. There were no related party transactions during the period ended
September 30, 2009, and no amounts were included in accounts payable and accrued liabilities as at
September 30, 2009. All transactions were recorded at their exchange amounts.
10. COMPREHENSIVE INCOME (LOSS)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Loss (income) attributable to common shareholders |
|
|
2,385 |
|
|
|
(4,160 |
) |
|
|
9,357 |
|
|
|
1,221 |
|
Reclassification of unrealized gain on marketable securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on cash equivalents and marketable securities |
|
|
2 |
|
|
|
(30 |
) |
|
|
2 |
|
|
|
(31 |
) |
Unrealized gain (loss) on foreign exchange |
|
|
|
|
|
|
67 |
|
|
|
|
|
|
|
(3 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss (income) |
|
|
2,383 |
|
|
|
(4,197 |
) |
|
|
9,355 |
|
|
|
1,255 |
|
11. SUBSEQUENT EVENTS
The Company has performed an evaluation of subsequent events through November 5, 2009, the date the
Company issued these financial statements. Based on our evaluation, no material events have
occurred requiring financial statement disclosure.
21
|
|
|
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:
|
|
|
timing and details of any corporate partnership agreements
with a third party in regards to our product candidates; |
|
|
|
|
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 on terms acceptable to us; |
|
|
|
|
a corporate partner may change the development plan or we
may change the development plan depending on availability of
funding; |
|
|
|
|
dependence on the development and commercialization of our product candidates; |
|
|
|
|
the risk that previous clinical trial results may not be
indicative of results in future studies; |
22
|
|
|
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; |
|
|
|
|
uncertainties regarding the safety and effectiveness of our products and technologies; |
|
|
|
|
the timing, expense and uncertainty associated with the
development and regulatory approval process for products; |
|
|
|
|
uncertainties regarding our future operating results, and
the risk that the our product candidates will not obtain the
requisite regulatory approvals to commercialize or that the
future sales of our product candidates 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; |
|
|
|
|
our 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 us 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 our 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. |
23
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 |
|
|
|
|
our current capital resources, 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.
24
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:
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Evaluating a survival benefit for OGX-011 in combination with first-line docetaxel
treatment in approximately 800 men with CRPC; and |
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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:
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The availability and receipt of additional funding from partnering, equity or
debt; and |
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ii) |
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Any partners concurrence with this development plan. |
OGX-011 has received Fast Track designations from the U.S. Food & Drug Administration (FDA) for
the treatment of progressive metastatic prostate cancer in combination with docetaxel for both
first and second-line docetaxel treatment. The FDA has agreed on the design of two phase 3
registration trials, each in CRPC, 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, are described below:
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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; |
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The 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 |
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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. In the multivariate analysis, patients treated with
OGX-011 had a rate of death of 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). |
25
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.
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 which supported the registration of docetaxel as first-line
chemotherapy in patients with CRPC. Due to the results of our phase 2 trial, our 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 47 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, 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 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 OGX-427 with docetaxel at both dose levels was also well tolerated. This data is
subject to further analysis.
Circulating tumor cells (CTCs), an emerging metric to assess treatment effect, were evaluated at
baseline before treatment and during OGX-427 treatment as a monotherapy. 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 type of cancer.
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.
26
A second investigator-sponsored phase 1 clinical trial evaluating OGX-427 when administered
directly into the bladder in patients with bladder cancer was initiated in August 2009. The study,
which will enroll up to 30 patients with bladder cancer, is designed to determine the safety and
potential benefit of OGX-427 administered directly into the bladder using a catheter, which is
known as intravesical instillation. In addition, the study will measure the direct effect of
OGX-427 on expression of Hsp27 in bladder tumor cells as well as determine the pharmacokinetics and
pharmacodynamics of OGX-427 when delivered by intravesical instillation. This
investigator-sponsored study is funded by the National Cancer Institute of Canada (NCIC).
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.
27
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 auditing 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.
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 September 30, 2009 was nil. The Company expects that all
severance liabilities relating to transaction-related workforce reductions will be paid out by
November 2009, and the amount owing at September 30, 2009 was $3,000.
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 nine month periods
ended September 30, 2009. The consolidated results of operations for the three and nine month
periods ended September 30, 2008 include the results of operations of OncoGenex Technologies for
the full three and nine month periods ended September 30, 2008 and the results of OncoGenex
Pharmaceuticals, Inc. following the completion of the Arrangement on August 21, 2008. 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 September 30, 2009 Compared to the Three Months Ended September 30, 2008
R&D expenses for the three months ended September 30, 2009 decreased to $1.5 million from
$1.6 million for the three months ended September 30, 2008, due mainly to lower costs associated
with the development of OGX-427 in 2009.
G&A expenses for the three months ended September 30, 2009 decreased to $0.9 million from
$1.0 million for the three months ended September 30, 2008, due mainly to lower corporate expenses
as compared to the prior period, which included additional transition expenses resulting from the
reverse takeover of Sonus.
Interest income for the three months ended September 30, 2009 decreased to $5 thousand from $51
thousand for the three months ended September 30, 2008 due mainly to lower cash equivalents and
short-term investments.
Other for the three months ended September 30, 2009 decreased to $24 thousand in income from $246
thousand in income for the three months ended September 30, 2008. The income earned in 2009 was due
to
the gains on sales of equipment and foreign exchange gains, as compared to foreign exchange gains
and a reversal of convertible debenture interest in the 2008 period.
28
Nine months Ended September 30, 2009 Compared to the Nine months Ended September 30, 2008
R&D expenses for the nine months ended September 30, 2009 increased to $6.8 million from
$3.6 million for the nine months ended September 30, 2008, due mainly to OGX-011 and OGX-427
development costs, an increase in employee expenses and higher facility costs resulting from the
reverse takeover of Sonus. Also included in the nine months ended September 30, 2008 was a SRED
claim of $0.6 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. The SRED program is a Canadian federal tax incentive program that
encourages Canadian businesses to conduct research and development in Canada.
G&A expenses for the nine months ended September 30, 2009 increased to $2.7 million from
$2.2 million for the nine months ended September 30, 2008, due mainly to higher employee expenses
and increased costs associated with operating as a public company.
Interest income for the nine months ended September 30, 2009 decreased to $41 thousand from $142
thousand for the nine months ended September 30, 2008. Of the $142 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 nine months ended September 30, 2009 increased to $79 thousand in income from $54
thousand in expense for the nine months ended September 30, 2008. The income earned in 2009 was due
to the gains on sales of equipment and foreign exchange gains, as compared to 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 $57 million since
the inception of OncoGenex Technologies through September 30, 2009. OncoGenex 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.
As at September 30, 2009, OncoGenex had cash, cash equivalents, and short-term investments of
$12.5 million in the aggregate as compared to cash, cash equivalents and short-term investments of
$12.4 million as at December 31, 2008. As at September 30, 2009, OncoGenex does not have any
borrowing or credit facilities available to it.
Cash Flows
Cash Used in Operations
For the nine months ended September 30, 2009 and 2008, net cash used in operations was $9.2 million
and $7.4 million, respectively. This increase in cash used in operations in the nine months ended
September 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, and the
purchase of OGX-011 and OGX-427 drug compound.
29
Cash Provided by Financing Activities
For the nine months ended September 30, 2009 and 2008, net cash provided by financing activities
was $9.4 million and $3 thousand, respectively. Net cash provided by financing activities in the
nine months ended September 30, 2009 was attributable to the net proceeds we received from the
issuance of common shares through a registered direct offering, and the proceeds from the issuance
of common shares on stock option exercises. Net cash provided by financing activities in the nine
months ended September 30, 2008 was attributable to the proceeds received from the issuance of
common shares on stock option exercises, offset by cash paid on the elimination of fractional
shares following the one-for-eighteen reverse stock split effected in connection with the
Arrangement.
Cash Used/Provided by Investing Activities
Net cash provided by investing activities for the nine months ended September 30, 2009 and 2008 was
$2.3 million and $8.8 million, respectively. Net cash provided by investing activities in the nine
months ended September 30, 2009 was due to transactions involving marketable securities in the
normal course of business. Net cash provided by investing activities in the nine months ended
September 30, 2008 was due to the reverse takeover of Sonus and 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
We believe that our cash, cash equivalents and short-term investments will be sufficient to fund
our currently planned operations into the fourth quarter of 2010, including:
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completing partnering discussions related to OGX-011; |
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completing follow-up monitoring visits related to its completed phase
2 clinical trials of OGX-011; |
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completing follow-up monitoring visits related to the Phase 1 clinical
trial evaluating OGX-427 as a monotherapy in patients with solid
tumors and continuing evaluation of OGX-427 in combination with
docetaxel in patients with solid tumors; |
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continuing an investigator-sponsored phase 1 clinical trial evaluating
OGX-427 treatment in patient with bladder cancer; |
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continuing critical path initiatives including manufacturing and
clinical trial readiness activities in anticipation of OGX-011 Phase 3
clinical trials; and |
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meeting working capital needs, capital expenditures and general corporate purposes. |
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 castrate
resistant prostate cancer (CRPC). We are seeking 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. We may also seek additional funding
through the licensing or sale of certain of our product candidates, or
through private or public offerings of our equity securities or debt financings.
30
Our future capital requirements depend on many factors, including:
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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; |
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timing and costs of clinical trials, preclinical development and regulatory approvals; |
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timing and cost of drug discovery and research and development; |
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entering into new collaborative or product license agreements for
products in our pipeline; and |
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costs related to obtaining, defending and enforcing patents. |
As we are
presently drafting definitive agreements, we believe that we are on track to secure a partnership for OGX-011. There can be no assurance that we will be able to obtain additional funding on terms favorable to
us, or at all. 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 all or part of our
operations.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet financing arrangements at September 30, 2009.
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
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September 30, |
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December 31, |
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(In thousands) |
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2009 |
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2008 |
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$ |
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$ |
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Total assets |
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14,584 |
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14,790 |
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Total liabilities |
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3,576 |
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4,083 |
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Shareholders equity |
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11,008 |
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10,707 |
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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, offset by proceeds
from the issuance of common shares through a registered direct offering. The decrease in
liabilities from December 31, 2008 relates predominantly to the payment in 2009 of manufacturing
costs included in Accounts Payable at year end.
31
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. |
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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 September 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.
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Item 4. |
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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 September 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 its internal control over financial reporting (as defined
in Rule 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended September 30, 2009
that have materially affected, or are reasonably likely to materially affect, the Companys
internal control over financial reporting.
32
PART II. OTHER INFORMATION
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 5. Other Information
Employment Agreements
The Company and OncoGenex Technologies
have entered into employment agreements with Scott Cormack, the Company’s
President and Chief Executive Officer, effective November 4, 2009 (the
“Cormack Agreement”) and Stephen Anderson, the Company’s
Chief Financial Officer, effective November 4, 2009 (the “Anderson
Agreement”). The Company has also entered into an employment agreement
with Cindy Jacobs, the Company’s Executive Vice President and Chief
Medical Officer, effective November 3, 2009 (the “Jacobs
Agreement”). The Cormack Agreement, Anderson Agreement and Jacobs
Agreement, which supersede the prior employment agreements with
Mr. Cormack, Mr. Anderson and Dr. Jacobs, respectively, are
intended to provide a general update of terms and to conform to public company
practices. Certain key terms of the Cormack Agreement, Anderson Agreement and
Jacobs Agreement are described below. Each description is qualified in its
entirety by reference to the full text of the applicable employment agreement.
Copies of the Cormack Agreement, Anderson Agreement and Jacobs Agreement are
attached hereto as Exhibits 10.25, 10.26 and 10.27, respectively, and
incorporated herein by reference.
Cormack Agreement
Under the Cormack Agreement, OncoGenex
Technologies is obligated to pay Mr. Cormack an annual base salary of not
less than Cdn.$345,000. Mr. Cormack is also eligible to receive a
discretionary annual incentive bonus constituting up to 40% of
Mr. Cormack’s base salary. Such percentage may be modified by the
board of directors or compensation committee of the Company from time to time.
The Cormack Agreement provides
Mr. Cormack with termination benefits in the event Mr. Cormack is
terminated without “cause” or for “disability” (each as
defined in the Cormack Agreement), or if Mr. Cormack resigns for
“good reason”, which is defined in the Cormack Agreement to mean
any of the following without Mr. Cormack’s prior written consent:
(i) the relocation of Mr. Cormack’s primary work location by more
than 40 miles from the current location of OncoGenex Technologies’
Canadian office in Vancouver, British Columbia; (ii) a material reduction
of Mr. Cormack’s base salary or employee benefits; (iii) any
material reduction or diminution of Mr. Cormack’s authority or
responsibilities; (iv) a fundamental breach of the Cormack Agreement; or
(v) the failure of any successor of the Company to expressly in writing
assume OncoGenex Technologies’ and the Company’s obligations under
the Cormack Agreement, in each case, provided that Mr. Cormack has
provided OncoGenex Technologies with two months advance written notice and an
opportunity to cure such breach during such two-month period (each termination
without “cause” or for “disability” of
Mr. Cormack’s employment, or Mr. Cormack’s resignation
for “good reason”, an “Involuntary Termination”).
33
The Cormack Agreement provides that if
there is an Involuntary Termination, OncoGenex Technologies will be obligated
to pay Mr. Cormack a lump sum equal to 18 months of his then-current
base salary. In addition, Mr. Cormack will receive continued entitlement
under OncoGenex Technologies’ group medical, dental and insurance plans,
excluding short and long term disability plans and pension plans, to which
Mr. Cormack and his family are entitled at Mr. Cormack’s
termination date, to the extent such benefit plans permit, for 18 months
(the “Cormack Benefit Plan Severance Period”) or until Mr. Cormack
becomes employed elsewhere wherein comparable benefits are provided, whichever
date comes first. To the extent continuance of a benefit plan, excluding short
and long term disability plans and pension plans, is not permitted, OncoGenex
Technologies will be obligated to pay Mr. Cormack an amount equal to the
sum Mr. Cormack would be required to pay to receive comparable benefits
for the Cormack Benefit Plan Severance Period. Notwithstanding the terms of any
equity compensation plan of the Company or any agreement in connection
therewith, if there is an Involuntary Termination, then the time-based vesting
restrictions (if any) will immediately lapse on an additional number of shares
under all of Mr. Cormack’s outstanding compensatory equity in the
Company (which includes any outstanding stock options granted to
Mr. Cormack under the Company’s equity compensation plans) that
would have time-vested if Mr. Cormack had continued in employment for
18 months following his Involuntary Termination.
The Cormack Agreement provides for
additional termination benefits if there is an Involuntary Termination during
the period beginning three months before and ending 12 months after a
“change in control” of the Company (as defined in the Cormack
Agreement) or if such Involuntary Termination is required by the merger
agreement, purchase agreement or other instrument relating to such change in
control or such Involuntary Termination is made at the express request of the
other party (or parties) to the transaction constituting such change in control
(each, a “Change in Control Termination”). Upon a Change in Control
Termination, OncoGenex Technologies will be obligated to pay Mr. Cormack
24 months of his then-current base salary, plus a sum equal to 12 months
of his average monthly bonus earnings, where such average is calculated over
the 24 month period immediately preceding Mr. Cormack’s
termination date and based on Mr. Cormack’s bonuses paid in such
24 month period. In addition, Mr. Cormack will receive continued
entitlement under OncoGenex Technologies’ benefit plans as described
above (or an amount equal to the sum Mr. Cormack would be required to pay
to receive comparable benefits if such continued entitlement is not permitted
as described above), except that the Cormack Benefit Plan Severance Period will
be 24 months instead of 18 months. Notwithstanding the terms of any
equity compensation plan of the Company or any agreement in connection
therewith, upon a Change in Control Termination, all vesting restrictions (if
any) will immediately lapse on all of Mr. Cormack’s compensatory
equity in the Company effective as of his termination date.
All termination benefits in the event
of an Involuntary Termination or Change in Control Termination are subject to
Mr. Cormack’s execution, delivery and non-revocation of a general release
of all litigation and other claims against OncoGenex Technologies, and the
Company and all affiliates.
The Cormack Agreement also includes
certain indemnification, non-solicitation, non-compete, non-disparagement and
confidentiality provisions. The indemnification agreements in effect between
the Company and Mr. Cormack and between OncoGenex Technologies and
Mr. Cormack will remain in effect.
34
Anderson Agreement
Under the Anderson Agreement, OncoGenex
Technologies is obligated to pay Mr. Anderson an annual base salary of not
less than Cdn.$210,000. Mr. Anderson is also eligible to receive a
discretionary annual incentive bonus constituting up to 25% of
Mr. Anderson’s base salary. Such percentage may be modified by the
board of directors or compensation committee of the Company from time to time.
The Anderson Agreement provides
Mr. Anderson with termination benefits in the event Mr. Anderson is
terminated without “cause” or for “disability” (each as
defined in the Anderson Agreement), or if Mr. Anderson resigns for
“good reason”, which is defined in the Anderson Agreement to mean
any of the following without Mr. Anderson’s prior written consent:
(i) the relocation of Mr. Anderson’s primary work location by
more than 40 miles from the current location of OncoGenex Technologies’
Canadian office in Vancouver, British Columbia; (ii) a material reduction
of Mr. Anderson’s base salary or employee benefits; (iii) any
material reduction or diminution of Mr. Anderson’s authority or
responsibilities; (iv) a fundamental breach of the Anderson Agreement; or
(v) the failure of any successor of the Company to expressly in writing
assume OncoGenex Technologies’ and the Company’s obligations under
the Anderson Agreement, in each case, provided that Mr. Anderson has
provided OncoGenex Technologies with one month advance written notice and an
opportunity to cure such breach during such one-month period (each termination
without “cause” or for “disability” of Mr.
Anderson’s employment, or Mr. Anderson’s resignation for
“good reason”, an “Involuntary Termination”).
The Anderson Agreement provides that if
there is an Involuntary Termination, OncoGenex Technologies will be obligated
to pay Mr. Anderson a lump sum equal to nine months of his then-current
base salary. In addition, Mr. Anderson will receive continued entitlement
under OncoGenex Technologies’ group medical, dental and insurance plans,
excluding short and long term disability plans and pension plans, to which
Mr. Anderson and his family are entitled at Mr. Anderson’s
termination date, to the extent such benefit plans permit, for nine months (the
“Anderson Benefit Plan Severance Period”) or until
Mr. Anderson becomes employed elsewhere wherein comparable benefits are
provided, whichever date comes first. To the extent continuance of a benefit
plan, excluding short and long term disability plans and pension plans, is not
permitted, OncoGenex Technologies will be obligated to pay Mr. Anderson an
amount equal to the sum Mr. Anderson would be required to pay to receive
comparable benefits for the Anderson Benefit Plan Severance Period.
Notwithstanding the terms of any equity compensation plan of the Company or any
agreement in connection therewith, if there is an Involuntary Termination, the
time-based vesting restrictions (if any) will immediately lapse on an
additional number of shares under all of Mr. Anderson’s outstanding
compensatory equity in the Company (which includes any outstanding stock
options granted to Mr. Anderson under the Company’s equity
compensation plans) that would have time-vested if Mr. Anderson had
continued in employment for nine months following his Involuntary Termination.
35
The Anderson Agreement provides for
additional termination benefits if there is an Involuntary Termination during
the period beginning three months before and ending 12 months after a
“change in control” of the Company (as defined in the Anderson
Agreement) or if such Involuntary Termination is required by the merger
agreement, purchase agreement or other instrument relating to such change in
control or such Involuntary Termination is made at the express request of the
other party (or parties) to the transaction constituting such change in control
(each, a “Change in Control Termination”). Upon a Change in Control
Termination, OncoGenex Technologies will be obligated to pay Mr. Anderson
12 months of his then-current base salary, plus a sum equal to 12 months
of his average monthly bonus earnings, where such average is calculated over
the 24 month period immediately preceding Mr. Anderson’s
termination date and based on Mr. Anderson’s bonuses paid in such
24 month period. In addition, Mr. Anderson will receive continued
entitlement under OncoGenex Technologies’ benefit plans as described
above (or an amount equal to the sum Mr. Anderson would be required to pay
to receive comparable benefits if such continued entitlement is not permitted
as described above), except that the Anderson Benefit Plan Severance Period
will be 12 months instead of nine months. Notwithstanding the terms of any
equity compensation plan of the Company or any agreement in connection
therewith, upon a Change in Control Termination, all vesting restrictions (if
any) will immediately lapse on all of Mr. Anderson’s compensatory
equity in the Company effective as of his termination date.
All termination benefits in the event
of an Involuntary Termination or Change in Control Termination are subject to
Mr. Anderson’s execution, delivery and non-revocation of a general
release of all litigation and other claims against OncoGenex Technologies, and
the Company and all affiliates.
The Anderson Agreement also includes
certain indemnification, non-solicitation, non-compete, non-disparagement and
confidentiality provisions. The indemnification agreements in effect between
the Company and Mr. Anderson and between OncoGenex Technologies and
Mr. Anderson will remain in effect.
Jacobs Agreement
Under the Jacobs Agreement, the Company
is obligated to pay Dr. Jacobs an annual base salary of not less than
$360,000. Dr. Jacobs is also eligible to receive a discretionary annual
incentive bonus constituting up to 30% of Dr. Jacobs’ base salary.
Such percentage may be modified by the board of directors or compensation
committee of the Company from time to time.
The Jacobs Agreement provides
Dr. Jacobs with termination benefits in the event Dr. Jacobs is
terminated without “cause” or for “disability” (each as
defined in the Jacobs Agreement), or if Dr. Jacobs resigns for “good
reason”, which is defined in the Jacobs Agreement to mean any of the
following without Dr. Jacobs’ prior written consent: (i) the
relocation of Dr. Jacobs’ primary work location by more than 40
miles from the Company’s current location in Bothell, Washington;
(ii) a material reduction of Dr. Jacobs’ base salary or
employee benefits; (iii) any material reduction or diminution of
Dr. Jacobs’ authority or responsibilities; (iv) a material
breach of the Jacobs Agreement; or (v) the failure of any successor of the
Company to expressly in writing assume the Company’s obligations under
the Jacobs Agreement, in each case, provided that Dr. Jacobs has provided
the Company with 30 days advance written notice and an opportunity to cure
such breach during such 30-day period (each termination without
“cause” or for “disability” of Dr. Jacobs’
employment, or Dr. Jacobs’ resignation for “good
reason”, an “Involuntary Termination”).
36
The Jacobs Agreement provides that if
there is an Involuntary Termination, the Company will be obligated to pay Dr.
Jacobs a lump sum equal to 12 months of her then-current base salary. In
addition, if Dr. Jacobs elects to continue her (and her dependents’)
health insurance coverage under the Consolidated Omnibus Budget Reconciliation
Act of 1985 (“COBRA”), the Company must pay up to 12 months of
Dr. Jacobs’ monthly premium under COBRA, provided that the
Company’s obligation to pay the monthly premium will cease when
Dr. Jacobs becomes eligible to receive substantially equivalent health
coverage in connection with new employment. Notwithstanding the terms of any
equity compensation plan of the Company or any agreement in connection
therewith, if there is an Involuntary Termination, then the time-based vesting
restrictions (if any) will immediately lapse on an additional number of shares
under all of Dr. Jacobs’ outstanding compensatory equity in the
Company (which includes outstanding stock options granted to Dr. Jacobs
under the Company’s equity compensation plans) that would have
time-vested if Dr. Jacobs had continued in employment for 12 months
following her Involuntary Termination.
The Jacobs Agreement provides for
additional termination benefits if there is an Involuntary Termination during
the period beginning three months before and ending 12 months after a
“change in control” of the Company (as defined in the Jacobs
Agreement) or if such Involuntary Termination is required by the merger
agreement, purchase agreement or other instrument relating to such change in
control or such Involuntary Termination is made at the express request of the
other party (or parties) to the transaction constituting such change in control
(each, a “Change in Control Termination”). Upon a Change in Control
Termination, the Company will be obligated to pay Dr. Jacobs
15 months of her then-current base salary, plus a sum equal to
12 months of her average monthly bonus earnings, where such average is
calculated over the 24 month period immediately preceding
Dr. Jacobs’ separation from services and based on
Dr. Jacobs’ bonuses paid in such 24 month period. In addition,
the Company’s payment of monthly COBRA premiums as described above will
be for up to 15 months instead of up to 12 months. Notwithstanding
the terms of any equity compensation plan of the Company or any agreement in
connection therewith, upon a Change in Control Termination, all vesting
restrictions (if any) will immediately lapse on all of Dr. Jacobs’
compensatory equity in the Company effective as of her separation from service.
All termination benefits in the event
of an Involuntary Termination or Change in Control Termination are subject to
Dr. Jacobs’ execution, delivery and non-revocation of a general release
of all litigation and other claims against the Company and all affiliates.
The Jacobs Agreement also includes
certain indemnification, non-solicitation, non-compete, non-disparagement and
confidentiality provisions. The indemnification agreements in effect between
the Company and Dr. Jacobs and between OncoGenex Technologies and
Dr. Jacobs will remain in effect.
37
|
|
|
|
|
Exhibit |
|
|
Number |
|
Description |
|
|
|
|
|
|
2.1 |
(1) |
|
Arrangement Agreement between the Company and OncoGenex Technologies Inc. dated May 27,
2008 |
|
|
|
|
|
|
2.2 |
(2) |
|
First Amendment to Arrangement Agreement between the Company and OncoGenex Technologies
Inc. dated August 11, 2008 |
|
|
|
|
|
|
2.3 |
(2) |
|
Second Amendment to Arrangement Agreement between the Company and OncoGenex
Technologies Inc. dated August 15, 2008 |
|
|
|
|
|
|
3.1 |
(3) |
|
Amended and Restated Certificate of Incorporation (As Amended Through October 17, 1995) |
|
|
|
|
|
|
3.2 |
(4) |
|
Certificate of Amendment to Certificate of Incorporation filed on May 6, 1999 |
|
|
|
|
|
|
3.3 |
(5) |
|
Certificate of Correction filed on March 9, 2009 to Certificate of Amendment filed on
May 6, 1999 |
|
|
|
|
|
|
3.4 |
(6) |
|
Certificate of Amendment to Certificate of Incorporation filed on May 7, 2004 |
|
|
|
|
|
|
3.5 |
(5) |
|
Certificate of Correction filed on March 9, 2009 to Certificate of Amendment filed on
May 7, 2004 |
|
|
|
|
|
|
3.6 |
(2) |
|
Certificate of Amendment to Certificate of Incorporation filed on August 20, 2008 |
|
|
|
|
|
|
3.7 |
(7) |
|
Third Amended and Restated Bylaws of Oncogenex Pharmaceuticals, Inc. |
|
|
|
|
|
|
4.1 |
(2) |
|
Specimen Certificate of Common Stock |
|
|
|
|
|
|
4.2 |
(8) |
|
Amended and Restated Rights Agreement dated as of July 24, 2002 between the Company and
U.S. Stock Transfer Corporation |
|
|
|
|
|
|
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 |
|
|
|
|
|
|
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 |
|
|
|
|
|
|
4.5 |
(11) |
|
Third Amendment to Amended and Restated Rights Agreement dated May 27, 2008 between the
Company and Computershare Trust Company, N.A. |
|
|
|
|
|
|
4.6 |
(1) |
|
Form of Escrow Agreement between the Company, Computershare Trust Company of Canada and
former shareholders and debentureholders of OncoGenex Technologies Inc. |
|
|
|
|
|
|
4.7 |
(1) |
|
Form of OncoGenex Voting Agreement |
|
|
|
|
|
|
4.8 |
(1) |
|
Form of Sonus Voting Agreement |
|
|
|
|
|
|
10.1 |
(12) |
|
Sonus Pharmaceuticals, Inc. Incentive Stock Option, Nonqualified Stock Option and
Restricted Stock Purchase Plan 1991 (the 1991 Plan), as amended |
38
|
|
|
|
|
Exhibit |
|
|
Number |
|
Description |
|
|
|
|
|
|
10.2 |
(12) |
|
Form of Incentive Option Agreement (pertaining to the 1991 Plan) |
|
|
|
|
|
|
10.3 |
(12) |
|
Form of Sonus Pharmaceuticals, Inc. Nonqualified Stock Option Agreement under the 1991
Plan |
|
|
|
|
|
|
10.4 |
(13) |
|
Sonus Pharmaceuticals, Inc. 1999 Nonqualified Stock Incentive Plan (the 1999 Plan) |
|
|
|
|
|
|
10.5 |
(13) |
|
Form of Sonus Pharmaceuticals, Inc. Nonqualified Stock Option Agreement under the 1999
Plan |
|
|
|
|
|
|
10.6 |
(13) |
|
Form of Sonus Pharmaceuticals, Inc. Restricted Stock Purchase Agreement under the 1999
Plan |
|
|
|
|
|
|
10.7 |
(14) |
|
Sonus Pharmaceuticals, Inc. 2000 Stock Incentive Plan (the 2000 Plan) |
|
|
|
|
|
|
10.8 |
(15) |
|
First Amendment to Sonus Pharmaceuticals, Inc. 2000 Plan |
|
|
|
|
|
|
10.9 |
(14) |
|
Form of Sonus Pharmaceuticals, Inc. Stock Option Agreement (pertaining to the 2000 Plan) |
|
|
|
|
|
|
10.10 |
(16) |
|
Sonus Pharmaceuticals, Inc. 2007 Performance Incentive Plan (the 2007 Plan) |
|
|
|
|
|
|
10.11 |
(17) |
|
Form of Sonus Pharmaceuticals, Inc. Stock Option Agreement (pertaining to the 2007 Plan) |
|
|
|
|
|
|
10.12 |
(17) |
|
Form of Sonus Pharmaceuticals, Inc. Restricted Stock Purchase Agreement under the 2007
Plan |
|
|
|
|
|
|
10.13 |
(18) |
|
OncoGenex Technologies Inc. Amended and Restated Stock Option Plan |
|
|
|
|
|
|
10.14 |
(19) |
|
Stock Option Assumption, Amending and Confirmation Agreement dated as of August 21,
2008 between the Company and OncoGenex Technologies Inc. |
|
|
|
|
|
|
10.15 |
(20) |
|
OncoGenex Pharmaceuticals, Inc. Short Term Incentive Awards Program |
|
|
|
|
|
|
10.16 |
(20) |
|
Agreement and Consent Form (related to the Short Term Incentive Awards Program) |
|
|
|
|
|
|
10.17 |
(20) |
|
Director Compensation Policy |
|
|
|
|
|
|
10.18 |
(12) |
|
Form of Indemnification Agreement for Officers and Directors of the Company |
|
|
|
|
|
|
10.19 |
(18) |
|
Form of Indemnification Agreement between OncoGenex Technologies Inc. and each of Scott
Cormack, Stephen Anderson and Cindy Jacobs |
|
|
|
|
|
|
10.20 |
(18) |
|
Form of Indemnification Agreement between OncoGenex Technologies Inc. and Neil
Clendeninn |
|
|
|
|
|
|
10.21 |
(21) |
|
Severance/Change in Control Agreement dated January 11, 2008 between the Company and
Michael Martino |
|
|
|
|
|
|
10.22 |
(2) |
|
Executive Termination Agreement and General Release dated August 21, 2008 between the
Company and Michael Martino |
|
|
|
|
|
|
10.23 |
(21) |
|
Severance/Change in Control Agreement dated January 11, 2008 between the Company and
Alan Fuhrman |
|
|
|
|
|
|
10.24 |
(2) |
|
Executive Termination Agreement and General Release dated August 21, 2008 between the
Company and Alan Fuhrman |
|
|
|
|
|
|
10.25 |
|
|
Employment Agreement between OncoGenex Technologies Inc. and the Company and Scott
Cormack dated as of November 4, 2009 |
|
|
|
|
|
|
10.26 |
|
|
Employment Agreement between OncoGenex Technologies Inc. and the Company and Stephen
Anderson dated as of November 4, 2009 |
|
|
|
|
|
|
10.27 |
|
|
Employment Agreement between the Company and Cindy Jacobs dated as of November 3, 2009 |
|
|
|
|
|
|
10.28 |
(22) |
|
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) |
39
|
|
|
|
|
Exhibit |
|
|
Number |
|
Description |
|
|
|
|
|
|
10.29 |
(22) |
|
Form of Purchase Warrant related to the Securities Purchase Agreement |
|
|
|
|
|
|
10.30 |
(23) |
|
Form of Purchase Warrant issued to Schering AG |
|
|
|
|
|
|
10.31 |
(22) |
|
Registration Rights Agreement dated as of August 15, 2005 by and among the Company and
the investors named therein |
|
|
|
|
|
|
10.32 |
(24) |
|
Lease by and between BMR-217th Place LLC and the Company dated as of
November 21, 2006 |
|
|
|
|
|
|
10.33 |
(25) |
|
First Amendment to Lease by and between BMR-217th Place LLC and the Company
dated as of August 17, 2007 |
|
|
|
|
|
|
10.34 |
(26) |
|
Second Amendment to Lease by and between BMR-217th Place LLC and the Company
dated as of January 28, 2008 |
|
|
|
|
|
|
10.35 |
(6) |
|
Amended and Restated License Agreement effective as of July 2, 2008 by and between
OncoGenex Technologies Inc. and Isis Pharmaceuticals, Inc. (OGX-011)* |
|
|
|
|
|
|
10.36 |
(27) |
|
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)* |
|
|
|
|
|
|
10.37 |
(2) |
|
Second Amending Agreement and Consent as of August 7, 2008 between The University of
British Columbia and OncoGenex Technologies Inc. (OGX-011) |
|
|
|
|
|
|
10.38 |
(27) |
|
Collaboration and License Agreement between OncoGenex Technologies Inc. and Isis
Pharmaceuticals, Inc. effective as of January 5, 2005 (OGX-427)* |
|
|
|
|
|
|
10.39 |
(27) |
|
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)* |
|
|
|
|
|
|
10.40 |
(2) |
|
Second Amending Agreement as of August 7, 2008 between The University of British
Columbia and OncoGenex Technologies Inc. (OGX-427) |
|
|
|
|
|
|
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 |
|
|
|
|
|
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. |
40
|
|
|
(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 September 30, 2000. |
|
(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 Companys current report on Form 8-K filed on August 18,
2005. |
|
(23) |
|
Incorporated by reference to the Schedule 13D filed by Schering Berlin Venture Corporation on
October 31, 2005. |
|
(24) |
|
Incorporated by reference to the Companys annual report on Form 10-K for the year ended
December 31, 2006. |
|
(25) |
|
Incorporated by reference to the Companys annual report on Form 10-K for the year ended
December 31, 2007. |
|
(26) |
|
Incorporated by reference to the Companys quarterly report on Form 10-Q for the quarter
ended March 31, 2008. |
|
(27) |
|
Incorporated by reference to the OncoGenex Technologies Inc. registration statement on Form
F-1, Amendment No. 1, filed on January 29, 2007. |
41
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.
|
|
Date: November 5, 2009 |
By: |
/s/ Stephen Anderson
|
|
|
|
Stephen Anderson |
|
|
|
Chief Financial Officer and Secretary
(Principal Financial and Accounting Officer) |
|
42
EXHIBIT INDEX
|
|
|
|
|
Exhibit |
|
|
Number |
|
Description |
|
|
|
|
|
|
10.25 |
|
|
Employment Agreement between OncoGenex Technologies Inc. and the
Company and Scott Cormack dated as of November 4, 2009 |
|
|
|
|
|
|
10.26 |
|
|
Employment Agreement between OncoGenex Technologies Inc. and the
Company and Stephen Anderson dated as of November 4, 2009 |
|
|
|
|
|
|
10.27 |
|
|
Employment Agreement between the Company and Cindy Jacobs dated as
of November 3, 2009 |
|
|
|
|
|
|
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 |
43