UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
FORM
10-Q/A
Amendment No. 1
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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 MARCH 31, 2010
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 217th 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, a
non-accelerated filer, or a smaller reporting company. 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 þ
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Non-accelerated filer o
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Smaller reporting company o |
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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 May 1, 2010 |
Common Stock, $0.001 par value
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6,375,461 |
EXPLANATORY NOTE
This amendment on Form 10-Q/A is being filed to correct a typographical error contained on page 24 of OncoGenex
Pharmaceuticals, Inc.s Form 10-Q originally filed on May 6, 2010. The remainder of the document is unchanged from the
original filing.
OncoGenex Pharmaceuticals, Inc.
Index to Form 10-Q/A
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Page
Number |
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3 |
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3 |
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4 |
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5 |
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6 |
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16 |
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26 |
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26 |
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27 |
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27 |
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Items 1, 2, 3, 4, and 5 are not applicable and therefore have been omitted |
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27 |
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2
PART I. FINANCIAL INFORMATION
Item 1. Consolidated Financial Statements
OncoGenex Pharmaceuticals, Inc.
Consolidated Balance Sheets
(Unaudited)
(In thousands of U.S. dollars)
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March 31, |
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December 31, |
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2010 |
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2009 |
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$ |
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$ |
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ASSETS |
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Current |
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Cash and cash equivalents[note 4] |
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45,475 |
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62,051 |
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Restricted cash |
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3,502 |
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Short-term investments [note 4] |
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2,111 |
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2,517 |
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Amounts receivable |
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2,823 |
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3,109 |
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Prepaid expenses |
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1,938 |
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722 |
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Total current assets |
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55,849 |
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68,399 |
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Property and equipment, net |
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80 |
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72 |
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Other assets |
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509 |
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509 |
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Total assets |
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56,438 |
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68,980 |
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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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6,824 |
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14,453 |
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Deferred Collaboration Revenue |
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10,000 |
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10,000 |
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Current portion of long-term obligations [note 6] |
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1,307 |
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1,328 |
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Total current liabilities |
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18,131 |
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25,781 |
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Deferred Collaboration Revenue, net of current |
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14,611 |
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16,528 |
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Long-term obligation, less current portion [note 6] |
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3,427 |
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3,712 |
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Total liabilities |
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36,169 |
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46,021 |
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Commitments and contingencies [note 7] |
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Shareholders equity: |
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Common shares: |
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$0.001 par value 11,019,930 shares authorized and
6,375,461 issued and outstanding at March 31, 2010
and 6,324,033 issued and
outstanding at December 31, 2009 |
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6 |
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6 |
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Additional paid-in capital |
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74,150 |
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73,798 |
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Accumulated deficit |
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(56,529 |
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(53,485 |
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Accumulated other comprehensive income |
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2,642 |
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2,640 |
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Total shareholders equity |
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20,269 |
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22,959 |
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Total liabilities and shareholders equity |
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56,438 |
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68,980 |
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Subsequent events [note 9] |
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See accompanying notes.
3
OncoGenex Pharmaceuticals, Inc.
Consolidated Statements of Operations
(Unaudited)
(In thousands of U.S. dollars, except per share and share amounts)
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Three months Ended |
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March 31, |
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2010 |
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2009 |
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$ |
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$ |
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COLLABORATION REVENUE |
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4,700 |
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EXPENSES |
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Research and development |
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6,380 |
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1,694 |
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General and administrative |
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1,350 |
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782 |
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Total expenses |
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7,730 |
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2,476 |
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OTHER INCOME (EXPENSE) |
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Interest income |
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5 |
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33 |
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Other |
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(19 |
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24 |
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Total other income (expense) |
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(14 |
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57 |
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Loss for the period before income taxes |
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3,044 |
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2,419 |
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Income tax expense (recovery) |
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(10 |
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Net loss |
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3,044 |
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2,409 |
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Basic and diluted loss per common share [note 5(e)] |
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0.48 |
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0.43 |
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Weighted average number of common shares
[note 5(e)] |
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6,333,272 |
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5,546,167 |
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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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Three months ended |
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March 31, |
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2010 |
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2009 |
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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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(3,044 |
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(2,409 |
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Add items not involving cash |
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Depreciation and amortization |
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12 |
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9 |
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Stock-based compensation [note 5(c)] |
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168 |
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76 |
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Changes in non-cash working capital items |
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Amounts receivable |
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286 |
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14 |
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Restricted cash |
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(3,502 |
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714 |
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Prepaid expenses |
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(1,216 |
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(44 |
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Accounts payable and accrued liabilities |
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(7,629 |
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(1,130 |
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Lease obligation |
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(306 |
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(267 |
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Deferred collaboration revenue |
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(1,917 |
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Cash used in operating activities |
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(17,148 |
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(3,037 |
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FINANCING ACTIVITIES |
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Proceeds from issuance of common stock under stock option and
employee purchase plans |
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185 |
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23 |
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Cash provided by financing activities |
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185 |
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23 |
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INVESTING ACTIVITIES |
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Proceeds from sale of investments |
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400 |
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4,784 |
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Purchase of property and equipment |
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(21 |
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(13 |
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Cash provided by investing activities |
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379 |
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4,771 |
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Effect of exchange rate changes on cash and cash equivalents |
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8 |
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18 |
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Increase (decrease) in cash and cash equivalents during the period |
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(16,576 |
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1,775 |
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Cash and cash equivalents, beginning of the period |
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62,051 |
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7,618 |
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Cash and cash equivalents, end of the period |
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45,475 |
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9,393 |
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Supplemental cash flow information |
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Property and equipment acquired under lease obligation |
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16 |
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See accompanying notes.
5
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 committed to the development and
commercialization of new therapies that address treatment resistance in cancer patients. 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, British Columbia (Canada) 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, 2009 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, 2009 and filed with the United States Securities and Exchange Commission (SEC)
on March 8, 2010.
The consolidated financial statements include the accounts of OncoGenex Pharmaceuticals, Inc., our
wholly owned subsidiary, OncoGenex Technologies, and our former wholly owned subsidiary, OncoGenex,
Inc. OncoGenex, Inc. ceased operations in 2009 and was subsequently dissolved. All intercompany
balances and transactions have been eliminated.
2. ACCOUNTING POLICIES
Recently Adopted Accounting Policies
In January 2010, the FASB issued amended guidance on fair value measurements and disclosures. The
new guidance requires additional disclosures regarding fair value measurements, amends disclosures
about postretirement benefit plan assets, and provides clarification regarding the level of
disaggregation of fair value disclosures by investment class. This guidance is effective for
interim and annual reporting periods beginning after December 15, 2009, except for certain Level 3
activity disclosure requirements that will be effective for reporting periods beginning after
December 15, 2010. Accordingly, we adopted this amendment in the quarter ended March 31, 2010,
except for the additional Level 3 requirements which will be adopted in 2011.
6
Recent Accounting Pronouncements
There were no recent accounting pronouncements which the Company expects would have any impact on
the consolidated financial position, results of operations or cash flows.
3. COLLABORATION AGREEMENT
On December 20, 2009, the Company, through its wholly-owned subsidiary, OncoGenex Technologies
Inc., entered into a Collaboration Agreement (the Collaboration Agreement) with Teva
Pharmaceutical Industries Ltd. (Teva) for the development and global commercialization of OGX-011
(and related compounds), a pharmaceutical compound designed to inhibit the production of clusterin,
a protein we believe is associated with cancer treatment resistance. Under the Collaboration
Agreement, Teva paid the Company upfront payments in the aggregate amount of $50 million, will pay
up to $370 million upon the achievement of developmental and commercial milestones and will pay
royalties at percentage rates ranging from the mid-teens to mid-twenties on net sales, depending on
aggregate annual net sales of the products containing OGX-011 and related compounds (Licensed
Product). The Company may be required to remit withholdings taxes to the Israeli Tax Authority of
up to $3 million. As a result $3 million is currently recorded as Restricted Cash pending the
Israeli Tax Authorities review of our claim, with a corresponding liability of $3 million included
in Accounts Payable and Accrued Liabilities as at March 31, 2010.
On the same date, the Company and Teva also entered into a stock purchase agreement pursuant to
which Teva made an additional $10 million equity investment in the Company at a 20% premium to a
thirty-day average closing price, resulting in 267,531 shares purchased at a price of $37.38 per
Share. The 20% share premium is included as consideration for the OGX-011 license and has been
included in deferred collaboration revenue.
Teva and the Company have developed a Clinical Development Plan under which three phase 3 clinical
trials will be initiated:
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a phase 3 clinical trial of the Licensed Product, referred to as the SATURN trial, for
second-line castrate resistant prostate cancer, expected to initiate in the second quarter
of 2010. The Company will have primary responsibility for the oversight of this trial; |
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a phase 3 clinical trial of the Licensed Product for first-line castrate resistant
prostate cancer, expected to initiate in the third quarter of 2010; and |
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a phase 3 clinical trial of the Licensed Product for first-line non-small cell lung
cancer (NSCLC), expected to initiate by early 2011. |
Funding responsibilities for the Clinical Development Plan will be allocated as follows:
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the Company will be required to spend $30 million in direct and indirect development
costs, and |
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Teva will fund all other expenses under the Clinical Development Plan. |
Revenue for the three months ended March 31, 2010 was $4.7 million, of which $1.9 million consisted
of partial recognition of deferred collaboration revenue representing OncoGenexs contribution to
the OGX-011 Phase III development plan under our Collaboration Agreement with Teva. The remaining
$2.8 million of revenue relates to OGX-011 manufacturing costs incurred by OncoGenex in the first
quarter of 2010 that are reimbursable from Teva on a cash basis, and is included in amounts
receivable at March 31, 2010. At March 31, 2010, a remaining balance of $24.6 million of the
up-front payment was recorded in deferred collaboration revenue. There were no revenues recorded in
the three months ended March 31, 2009.
7
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 level listed below:
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Level 1 Quoted prices in active markets for identical securities; |
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Level 2 Other significant observable inputs that are observable through corroboration
with market data (including quoted prices in active markets for similar securities); |
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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 financial instruments measured
at fair value on a recurring basis follows.
Financial Instruments
Cash
Significant amounts of cash are held on deposit with a large well established Canadian financial
institution.
U.S. Government and Agency 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.
8
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 of March 31, 2010, and indicates the fair value hierarchy of the
valuation techniques we utilized to determine such fair value:
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(in thousands) |
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Level 1 |
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Level 2 |
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Level 3 |
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Total |
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Marketable Securities |
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Money market securities |
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$ |
11,524 |
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$ |
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$ |
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$ |
11,524 |
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U.S. government securities |
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6,008 |
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6,008 |
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U.S. agency securities |
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300 |
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2,102 |
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2,402 |
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Corporate bonds and
commercial paper |
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5,699 |
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5,699 |
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|
$ |
17,832 |
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|
$ |
7,801 |
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$ |
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|
$ |
25,633 |
|
Marketable securities as at March 31, 2010 consist of the following:
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Gross |
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Gross |
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Amortized |
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Unrealized |
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Unrealized |
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Estimated |
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(in thousands) |
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Cost |
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Gain |
|
|
Loss |
|
|
Fair Value |
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market
securities |
|
$ |
11,524 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
11,524 |
|
U.S. government
securities |
|
|
6,007 |
|
|
|
1 |
|
|
|
|
|
|
|
6,008 |
|
U.S. agency
securities |
|
|
2,401 |
|
|
|
1 |
|
|
|
|
|
|
|
2,402 |
|
Corporate bonds and
commercial paper |
|
|
5,699 |
|
|
|
|
|
|
|
|
|
|
|
5,699 |
|
|
|
$ |
25,631 |
|
|
$ |
2 |
|
|
$ |
|
|
|
$ |
25,633 |
|
At March 31, 2010 $11,524,000 of money market securities, $5,000,000 of U.S. treasury securities,
$1,300,000 of other government debt securities, and $5,699,000 of Commercial paper in the above
tables are included in cash equivalents as the securities have maturities of 90 days or less at the
time of purchase. The remaining securities all mature within one year of the balance sheet date
and are included in short-term investments.
9
There were no significant realized or unrealized gains or losses on the sales of marketable
securities in the periods ended March 31, 2010, and no significant unrealized gains or losses are
included in accumulated
other comprehensive income as at March 31, 2010. Realized gains and losses are transferred out of
accumulated other comprehensive income into interest income using the specific identification
method.
All of the marketable securities held as of March 31, 2010 had maturities of one year or less. The
Company only invests in A (or equivalent) rated securities with maturities of one year or less.
The Company does not believe that there are any other than temporary impairments related to its
investment in marketable securities at March 31, 2010 given the quality of the investment
portfolio, its short-term nature, and subsequent proceeds collected on sale of securities that
reached maturity.
5. COMMON SHARES
[a] Authorized
11,019,930 authorized common voting share, par value of $0.001.
[b] Issued and Outstanding Shares
During the three month period ended March 31, 2010 the Company issued 51,428 common shares upon
exercise of stock options (period ended March 31, 2009 5,791). The Company issues new shares to
satisfy stock option exercises.
[c] Stock options
Stock Option Summary
As at March 31, 2010 the Company has reserved, pursuant to various plans, 798,033 common shares for
issuance upon exercise of stock options by employees, directors, officers and consultants of the
Company of which 70,801 are not currently subject to outstanding grants and are available for
future grant.
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, 2009 |
|
|
802,871 |
|
|
|
6.95 |
|
Option grants |
|
|
9,446 |
|
|
|
21.05 |
|
Option expirations |
|
|
(7,094 |
) |
|
|
108.00 |
|
Option exercises |
|
|
(51,428 |
) |
|
|
3.60 |
|
Option forfeitures |
|
|
(26,563 |
) |
|
|
7.35 |
|
|
|
|
|
|
|
|
Balance, March 31, 2010 |
|
|
727,232 |
|
|
|
6.37 |
|
On March 23, 2010, 4,723 stock options to purchase common shares of the Company were granted to
each of two newly appointed nonexecutive members of the board of directors for a total grant of
9,446 stock options.
10
The options vest quarterly over three years. The total estimated fair value of these awards is
$121,000 using the following assumptions:
|
|
|
|
|
Risk-free interest rates |
|
|
2.44 |
% |
Expected dividend yield |
|
|
0 |
% |
Expected life |
|
5 years |
|
Expected volatility |
|
|
73 |
% |
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, 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 |
|
|
|
March 31, |
|
(In thousands) |
|
2010 |
|
|
2009 |
|
|
|
$ |
|
|
$ |
|
Research and development |
|
|
69 |
|
|
|
22 |
|
General and administrative |
|
|
99 |
|
|
|
54 |
|
|
Total share-based compensation |
|
|
168 |
|
|
|
76 |
|
As at March 31, 2010 and December 31, 2009 the total unrecognized compensation expense related to
stock options granted is $1,684,000 and $1,910,000 respectively, which is expected to be recognized
into expense over a period of approximately four years.
[d] Stock Warrants
At March 31, 2010, there were warrants outstanding to purchase 183,385 shares of common
stock at exercise prices ranging from $74.70 to $79.56 per share and expiration dates
ranging from August 2010 to October 2010.
[e] Loss per Common Share
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
(In thousands except shares and per share amounts) |
|
2010 |
|
|
2009 |
|
Numerator |
|
|
|
|
|
|
|
|
Loss attributable to common shareholders as reported |
|
$ |
3,044 |
|
|
|
2,409 |
|
Denominator |
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding |
|
|
6,333,272 |
|
|
|
5,546,167 |
|
Basic and diluted loss per common share |
|
$ |
0.48 |
|
|
|
0.43 |
|
11
As of March 31, 2010 and December 31, 2009 a total of 910,617 and 986,256 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
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. 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 will be recognized as adjustments to restructuring
charges in future periods.
In June 2009 the Company revised its sublease income assumptions used to estimate the fair value of
the excess lease facility liability. These assumptions were subsequently revised again in December
2009. These changes in estimate resulted in increases in the fair value of the excess lease
liability and $494,000 and $3,457,000 in charges to research and development expense recorded in
June 2009 and December 2009, respectively, to reflect these changes in estimate. The estimated fair
value of the liability remaining at December 31, 2009 with respect to excess facilities was
$4,645,000. In the three months ended March 31, 2010, with respect to excess facilities, $337,000
was amortized into income through research and development expense, resulting in a remaining
liability of $4,308,000 at March 31, 2010.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining |
|
|
|
|
|
|
Amortization |
|
|
Remaining |
|
|
|
Liability at |
|
|
Payments |
|
|
of excess |
|
|
Liability |
|
(In thousands) |
|
December 31, 2009 |
|
|
made |
|
|
lease facility |
|
|
at March 31, 2010 |
|
Current portion
of excess lease
facility |
|
$ |
1,297 |
|
|
$ |
|
|
|
$ |
23 |
|
|
$ |
1,274 |
|
Long-term
portion of
excess lease
facility |
|
$ |
3,348 |
|
|
$ |
|
|
|
$ |
314 |
|
|
$ |
3,034 |
|
7. COMMITMENTS AND CONTINGENCIES
Teva Pharmaceutical Industries Ltd.
In December 2009, OncoGenex Pharmaceuticals, Inc., through its wholly-owned subsidiary, OncoGenex
Technologies, entered into a Collaboration Agreement with Teva for the development and global
commercialization of OGX-011 (and related compounds). Under the Collaboration Agreement, Teva made
upfront payments in the aggregate amount of $50 million, will pay up to $370 million upon the
achievement of developmental and commercial milestones and will pay royalties at percentage rates
ranging from the mid-teens to mid-twenties on net sales. The Company is required to contribute $30
million in direct and indirect costs towards the Clinical Development Plan. $4.7 million of the
total funding commitment has been incurred by OncoGenex as at March 31, 2010, and has been applied
against the funding responsibility for the OGX-011 development plan resulting in a remaining
deferred collaboration revenue balance of $24.6 million as at March 31, 2010. Teva will fund all
other expenses under the Clinical Development Plan.
12
Pursuant to the Collaboration Agreement, OncoGenex and Teva agreed to collaborate in the
development and global commercialization of OGX-011. Teva received the exclusive worldwide right
and license to develop and commercialize products containing OGX-011 and related compounds.
OncoGenex has an option to co-promote OGX-011 in the United States and Canada.
In addition to the development costs noted above, Teva is also responsible for all costs relating
to product commercialization including costs incurred in relation to the Companys co-promotion
option, except for start-up costs in advance of commercialization.
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., the Company is obligated to pay royalties on future product sales and
milestone payments of up to $10.2 million upon the achievement of specified product development
milestones related to OGX-427 and OGX-225.
In addition, we are required to pay to Isis 30% of all Non-Royalty Revenue we receive. Isis has
disclosed in its SEC filings that it is entitled to receive 30% of the up to $370 million in
milestone payments we may receive from Teva as part of the Collaboration Agreement; however, we
believe that certain of the milestone payments related to sales targets may qualify as Royalty
Revenue, and therefore be subject to the lesser payment obligations. No assurance can be provided
that we will be entitled to receive these milestone payments or, if we are, that the applicable
amount payable to Isis will be less than 30%. We are also 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.
We anticipate paying Isis $750,000 in 2010 upon the initiation of a phase 2 clinical trial of
OGX-427 in patients with castrate resistant prostate cancer (CRPC). We do not anticipate making
any royalty payments to Isis in 2010.
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.
To facilitate the execution and performance of the Collaboration Agreement with Teva, OncoGenex and
Isis agreed to amend the Isis License Agreement and the Company and UBC agreed to amend the UBC
License Agreement, in each case, effective December 19 and December 20, 2009, respectively.
The amendment to the Isis License Agreement provides, among other things, that if the Company is
the subject of a change of control with a third party, where the surviving company immediately
following such change of control has the right to develop and sell the product, then (i) a
milestone payment of $20 million will be due and payable to Isis 21 days following the first
commercial sale of the product in the United States; and (ii) unless such surviving entity had
previously sublicensed the product and a royalty rate payable to Isis by the Company has been
established, the applicable royalty rate payable to Isis will thereafter be the maximum amount
payable under the Isis License Agreement. Any non-royalty milestone amounts previously paid will be
credited toward the $20 million milestone if not already paid. As a result of the $10 million
milestone payment payable to Isis in relation to the Collaboration Agreement, the remaining amount
owing in the event of change of control discussed above is a maximum of $10 million. As the Company
has now licensed the product to Teva and established a royalty rate payable to Isis, no royalty
rate adjustments would apply if Teva acquires the Company and is the surviving company. If the
$30 million in advanced reimbursement of development activities has not been spent by OncoGenex
prior to the third anniversary of the Collaboration Agreement between OncoGenex and Teva, OncoGenex
will pay Isis an amount equal to 30% of any un-spent portion less $3.5 million. As of March 31,
2010, the unspent portion included on the balance sheet as deferred collaboration revenue was $24.6
million.
13
Bayer HealthCare LLC
On August 7, 2008, Sonus completed an exclusive in-licensing agreement with Bayer HealthCare LLC
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 in 2009. The payments 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 on
net future product sales in addition to aggregate milestone payments of up to $14,000,000 for
clinical development and regulatory milestones. No milestone payments are triggered prior to the
initiation of a phase 3 clinical trial. OncoGenex has the option to terminate this contract upon 60
days written notice to Bayer.
Lease Arrangements
The Company has an operating lease agreement for office space in Vancouver, Canada, which expires
in March 2011.
Future minimum annual lease payments under the Vancouver lease are as follows (in thousands):
|
|
|
|
|
2010 |
|
$ |
140 |
|
2011 |
|
|
47 |
|
|
|
|
|
Total |
|
$ |
187 |
|
In November 2006, prior to the Arrangement (note 1), Sonus entered into a non-cancellable operating
lease agreement for office space in Bothell, Washington, expiring in 2017. 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 $502,000 which was issued in 2010 and is included in
Restricted Cash. 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 $4,308,000 as at March 31, 2010 (note 6).
If the Company is unable to exit or sublet portions of this leased space, the future minimum annual
lease payments are as follows (in thousands):
|
|
|
|
|
2010 |
|
$ |
1,497 |
|
2011 |
|
|
2,055 |
|
2012 |
|
|
2,117 |
|
2013 |
|
|
2,180 |
|
2014 |
|
|
2,245 |
|
remainder |
|
|
7,150 |
|
|
|
|
|
Total |
|
$ |
17,244 |
|
14
Consolidated rent expense relating to both the Vancouver, Canada and Bothell, Washington offices
for the periods ended March 31, 2010 and 2009 was $621,000 and $499,000 respectively.
Guarantees and Indemnifications
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 us 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
March 31, 2010.
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.
8. COMPREHENSIVE INCOME (LOSS)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2010 |
|
|
2009 |
|
|
|
$ |
|
|
$ |
|
(In thousands) |
|
|
|
|
|
|
|
|
Loss for the period |
|
|
3,044 |
|
|
|
2,409 |
|
Unrealized loss on cash equivalents and marketable securities |
|
|
(2 |
) |
|
|
1 |
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
3,042 |
|
|
|
2,410 |
|
9. SUBSEQUENT EVENTS
The Company has performed an evaluation of events occurring subsequent to March 31, 2010. Based on
our evaluation, no material events have occurred requiring financial statement disclosure.
15
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 future financial and operating
results, plans, objectives, expectations and intentions, costs and expenses, interest rates,
outcome of contingencies, financial condition, results of operations, liquidity, business
strategies, cost savings, objectives of management and other statements that are not historical
facts. You can find many of these statements by looking for words like believes, expects,
anticipates, estimates, may, should, will, could, plan, intend, or similar
expressions in this document or in documents incorporated by reference in this document. We intend
that such forward-looking statements be subject to the safe harbors created thereby. Examples of
these forward-looking statements include, but are not limited to:
|
|
our anticipated future capital requirements and the terms of any capital financing agreements; |
|
|
|
progress and preliminary and future results of clinical trial conducted by us or our
collaborators; |
|
|
anticipated regulatory filings, requirements and future clinical trials conducted by us or
our partners; |
|
|
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:
|
|
uncertainties regarding our future operating results, and the risk that 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 or nil; |
|
|
future capital requirements and uncertainty of obtaining additional funding through debt or
equity financings on terms acceptable to us; |
|
|
dependence on Tevas ongoing commitment and ability to develop and commercialize OGX-011; |
|
|
dependence on the development and commercialization of our product candidates, particularly
on OGX-011; |
|
|
the risk that previous clinical trial results may not be indicative of results in future studies; |
|
|
|
the risk that results of research and preclinical studies may not be indicative of results in
humans; |
|
|
|
uncertainty relating to the timing and results of clinical trials; |
|
|
|
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; |
|
|
acceptance of our products by the medical community; |
|
|
|
the uncertainty associated with exiting or subleasing our excess office and laboratory space; |
|
|
our ability to build out our product candidate pipeline through product in-licensing or
acquisition activities; |
|
|
our future dependence on Teva to market and promote OGX-011 and to provide us with accurate
financial data; |
16
|
|
general competitive conditions within the drug development and pharmaceutical industry and
new developments or therapies that may not work in combination with our product candidates; |
|
|
our dependence on key employees; |
|
|
|
proper management of our operations will be critical to the success of the Company; |
|
|
|
the potential for product liability issues and related litigation; |
|
|
|
the potential for claims arising from the use of hazardous materials in our business; |
|
|
|
the potential inability to successfully protect and enforce our intellectual property rights; |
|
|
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 reliance on third parties to manufacture and supply our product candidates; |
|
|
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; |
|
|
volatility in the value of our common stock; and |
|
|
|
general economic conditions. |
You are cautioned not to place undue reliance on these forward-looking statements, which speak only
as of the date of this document or, in the case of documents referred to or incorporated by
reference, the date of those documents.
All subsequent written or oral forward-looking statements attributable to us or any person acting
on our behalf are expressly qualified in their entirety by the cautionary statements contained or
referred to in this section. We do not undertake any obligation to release publicly any revisions
to these forward-looking statements to reflect events or circumstances after the date of this
document or to reflect the occurrence of unanticipated events, except as may be required under
applicable U.S. securities law. If we do update one or more forward-looking statements, no
inference should be drawn that we will make additional updates with respect to those or other
forward-looking statements.
MD&A Overview
In Managements Discussion and Analysis of Financial Condition and Results of Operations, we
explain the general financial condition and the results of operations for our Company, including:
|
|
|
an overview of our business; |
|
|
|
|
results of operations and why those results are different from the
comparative period in the prior year; and |
|
|
|
|
capital resources we currently have, our capital requirements and
possible sources of additional funding for future capital
requirements. |
Overview of the Company
OncoGenex is a biopharmaceutical company committed to the development and commercialization of new
cancer therapies that address treatment resistance in cancer patients. We have five product
candidates in our 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.
17
Our 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 which we believe promote survival of tumor cells and are over-produced in
response to a variety of cancer treatments. Our 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 we believe 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, which have been in-licensed from Bayer, that demonstrate
activation of programmed cell death in pre-clinical models.
Product Candidate OGX-011
In December 2009, we announced our entry into the Collaboration Agreement with Teva, for the
development and global commercialization of OGX-011 (and related compounds targeting clusterin with
the exclusion of OGX-427 and OGX-225).
OncoGenex and Teva have developed a Clinical Development Plan under which three phase 3 clinical
trials will be initiated. We have designed two of the phase 3 clinical trials to evaluate the
clinical benefit of OGX- 011 in patients with castrate resistant prostate cancer (CRPC) and,
together with Teva, we are in the process of designing a third phase 3 clinical trial evaluating
the clinical benefit of OGX-011 in non-small cell lung cancer (NSCLC), as follows:
|
|
|
a phase 3 registration trial evaluating a survival benefit for OGX-011 in combination
with first-line docetaxel treatment in approximately 800 men with CRPC, expected to
initiate in the third quarter of 2010; |
|
|
|
a phase 3 registration trial, referred to as the SATURN trial, evaluating a durable
pain palliation benefit for OGX-011 in combination with docetaxel as second-line
chemotherapy in approximately 300 men with CRPC, expected to initiate in the second
quarter of 2010; and |
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a phase 3 registration trial evaluating a survival benefit for OGX-011 in combination
with first-line chemotherapy in at least 700 patients with NSCLC, expected to initiate in
early 2011. |
For detailed information regarding our relationship with Teva and the Collaboration Agreement,
refer to the discussion under the heading License and Collaboration Agreements Teva
Pharmaceutical Industries Ltd., in our 2009 Annual Report on Form 10-K filed on March 8, 2010.
During 2009, OGX-011 received Fast Track designations from the U.S. Food and 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, the SATURN trial, investigates pain
palliation as the primary endpoint for OGX-011 in combination with second-line chemotherapy.
In February of 2010, OGX-011 received written, scientific advice from the European Medicines Agency
(EMA) on the Companys development plan for OGX-011 for the treatment of men with CRPC. The input
received from the Committee for Medicinal Products for Human Use (CHMP) at the EMA was in overall
agreement with OncoGenexs development plan regarding the proposed preclinical studies and both the
study designs and analyses for the phase III trials. The CHMP also agreed that the intended safety
database would enable a sufficient qualified risk-benefit assessment for market approval.
18
Our phase 3 registration trials are designed to build on our phase 2 clinical trials, including:
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a randomized phase 2 trial evaluating the benefit of combining OGX-011 with first-line
docetaxel chemotherapy, the final results of which were presented during an oral
presentation at the 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 in our 2009 Annual Report
on Form 10-K filed on March 8, 2010 under the heading Summary of Final Results of OGX-011
Phase 2 Clinical Trial in First-Line Hormone Refractory Prostate Cancer. Due to the
results of our phase 2 trial, one of the phase 3 registration trials that will be
initiated in 2010 will evaluate the survival benefit of OGX-011 in patients treated with
first-line chemotherapy; and, |
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Durable pain palliation defined as pain palliation of 12 weeks or greater has been
observed in another phase 2 trial evaluating patients with metastatic CRPC who progressed
while receiving, or within 6 months of completing, first-line docetaxel treatment. Of the
patients on this trial who had pain or were on opioids for pain control and were retreated
with docetaxel as second-line treatment in combination with OGX-011, 46% 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 trial which supported the registration of docetaxel as
first-line chemotherapy in patients with CRPC. Due to the results of our phase 2 trial,
one of the phase 3 registration trials that will be initiated in 2010 will evaluate the
durable pain palliation benefit of OGX-011 in patients treated with second-line
chemotherapy. |
The protocol for the OGX-011 phase 3 registration trial in NSCLC that Teva is expected to initiate
in 2011 has yet to be finalized.
Product Candidate OGX-427
OGX-427 is a second generation antisense drug which in preclinical experiments, inhibits production
of Heat Shock Protein 27 (Hsp27) a cell survival protein found at elevated levels in many human
cancers including prostate, lung, breast, ovarian, bladder, renal, pancreatic, multiple myeloma and
liver cancer. Many anti-cancer therapies are known to further elevate Hsp27 levels. For example,
Hsp27 levels increased four-fold in prostate cancer patients after treatment with chemo- or hormone
therapy. Increased levels of Hsp27 in some human cancers are associated with metastases, poor
prognosis and resistance to radiation or chemotherapy.
OGX-427 is being evaluated in a Phase 1 study in patients with breast, prostate, ovarian, non-small
cell lung, or bladder cancer who have failed potentially curative treatments or for which a
curative treatment does not exist. This phase 1 trial has evaluated 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 as monotherapy. Subsequently, as defined by the protocol, an
800mg dose of OGX-427 in combination with docetaxel was evaluated, followed by a 1000mg dose of
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. At that time, 41 patients were enrolled who 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.
19
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 decrease 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 tumour 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 (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. Final results from this trial will be
presented at the ASCO 2010 Annual Meeting in June 2010.
An 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 36 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).
In January 2010, we announced that a second investigator-sponsored phase 2 clinical trial
evaluating OGX-427 when administered as a monotherapy to patients with CRPC has received grant
funding. The randomized, controlled phase 2 study will enroll up to 72 patients and is designed to
determine the potential benefit of OGX-427 by evaluating the number of patients who are without
disease progression at 12 weeks post study treatment with or without OGX-427. This phase 2 trial
will also measure the direct effect of OGX-427 on PSA levels, time to progression by PSA or
measurable disease, numbers of CTCs and other relevant secondary endpoints. The trial is expected
to start by mid 2010 following final analysis of phase 1 data and approval by Health Canada and the
institutional review board. The funds were awarded by a third party granting agency to Dr. Kim Chi,
a medical oncologist at the BC Cancer Agency, Research Scientist at the Vancouver Prostate Centre
and the principal investigator of the OGX-427 phase 2 trial.
Product Candidates OGX-225, SN2310 and CSP-9222
OGX-225 focuses on mechanisms of treatment resistance in cancer patients and is designed to address
treatment resistance by blocking the production of specific proteins which we believe promote
survival of tumor cells and are over-produced in response to a variety of cancer treatments.
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, which have been in-licensed from Bayer, that demonstrate activation of programmed cell
death in pre-clinical models.
20
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. We do not intend to initiate additional trials for SN2310
but rather will seek to out-license or sell this product candidate to a third party. OGX-225, an
inhibitor of insulin growth factor binding proteins 2 and 5, and CSP-9222 are in pre-clinical
development.
Collaboration Revenue
We recorded $4.7 million of collaboration revenue in connection with our OGX-011 Collaboration
Agreement with Teva in the three months ended March 31, 2010. At March 31, 2010, $24.6 million of
the upfront payment was included in the balance sheet line item Deferred Collaboration Revenue,
which we are amortizing over a period over the expected performance period of our deliverables
under this agreement. Management currently expects this performance period to end in the fourth
quarter of 2012. Further, we are eligible to receive payments of up to $370 million upon the
achievement of developmental and commercial milestones. At present, we are unable to predict the
timing or likelihood of such milestone payments, although we do not expect to receive any
milestone payments from Teva in the year ended December 31, 2010. There were no revenues in the
three months ended March 31, 2009. See note 3 in the Notes to Financial Statements for further
details on our collaboration with Teva.
Research and Development Expenses
Research and development (R&D) expenses consist primarily of costs for: milestone payments to
third parties; 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 our product candidates for use in our
clinical trials. We expect our R&D expenses to increase significantly in the future as we continue
to develop our product candidates. Currently, OncoGenex manages its clinical trials through
independent medical investigators at their sites and at hospitals.
Under the Collaboration Agreement with Teva, we are required to spend $30 million towards
development of OGX-011 which will include personnel costs for certain development activities. Teva
is required to fund all other expenses under the Clinical Development Plan. A total of $5.3 million
of costs incurred by the Company have been applied against the Companys $30 million funding
commitment, resulting in a remaining funding commitment of $24.6 million at March 31, 2010. We
expect compensation for our full time equivalent employee costs of between $1.5 and $2.5 million
per year from 2010 to 2012, which will be applied against our funding commitment, or reimbursed to
us from Teva on a cash basis. We expect to incur the remaining costs associated with the Clinical
Development Plan over the next three years.
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. In connection with
the Collaboration Agreement and pursuant to the terms of agreements between the Company and Isis
relating to OGX-011, the Company accrued a payment of $10 million to Isis, which was included in
R&D expenses in 2009. The Company also accrued a payment of approximately $333,333 to UBC pursuant
to the terms of their license agreement relating to OGX-011, which was also included in R&D
expenses in December 2009. Amounts owing to Isis and UBC at December 31, 2009 were paid in the
first quarter of 2010.
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.
21
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, if ever.
Our projects or intended R&D activities may be subject to change from time to time as we evaluate
our R&D priorities and available resources.
General and Administrative Expenses
General and administrative (G&A) expenses consist primarily of salaries and related costs for
our personnel in executive, business development, human resources, external communications,
finance and other administrative functions, as well as consulting costs, including market research
and business consulting. Other costs include professional fees for legal and accounting services,
insurance and facility costs. We believe that G&A resources are sufficient to carry on existing
development activities. We anticipate that G&A expenses will increase in the future as we continue
to expand our operating activities.
Restructuring Activities
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. 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 will be recognized as adjustments to restructuring
charges in future periods.
In June 2009 the Company revised its sublease income assumptions used to estimate the fair value of
the excess lease facility liability. These assumptions were subsequently revised again in December
2009. These changes in estimate resulted in increases in the fair value of the excess lease
liability and $494,000 and $3,457,000 in charges to research and development expense recorded in
June 2009 and December 2009, respectively, to reflect these changes in estimate. The estimated fair
value of the liability remaining at December 31, 2009 with respect to excess facilities was
$4,645,000. In the three months ended March 31, 2010, with respect to excess facilities $337,000
was amortized into income recorded within research and development expense, resulting in a
remaining liability of $4,308,000 at March 31, 2010.
Results of Operations
Three Months Ended March 31, 2010 Compared to the Three Months Ended March 31, 2009
Revenue for the first quarter ended March 31, 2010 was $4.7 million, of which $1.9 million
consisted of partial recognition of the non-refundable up-front payments received from Teva in
December 2009. The remaining $2.8 million of revenue relates to OGX-011 manufacturing costs
incurred by OncoGenex in the first quarter of 2010 that are reimbursable from Teva on a cash basis,
and is included in amounts receivable at March 31, 2010. At March 31, 2010, $24.6 million of the
upfront payment received from Teva was included on the Companys Balance Sheet as Deferred
Collaboration Revenue which we are amortizing over a period of approximately three years based on
the expected performance period of our deliverables under this agreement. No revenues were recorded
in the three months ended March 31, 2009. See note 3 in the Notes to Financial Statements for
further details on our collaboration with Teva.
22
Research and development expenses for the first quarter ended March 31, 2010 were $6.4 million,
compared to $1.7 million in the corresponding period of 2009, an increase consistent with the $4.7
million
of revenues in the first quarter of 2010. The increased research and development expenses in the
first quarter of 2010 were primarily due to manufacturing costs and upfront clinical trial costs
associated with the OGX-011 Phase III clinical trials, as well as increased employee expenses.
Clinical trial costs for the OGX-011 Phase III clinical trials are applied against the
non-refundable up-front payments received from Teva in December 2009, while manufacturing costs are
reimbursable from Teva on a cash basis.
G&A expenses for the three months ended March 31, 2010 were $1.4 million compared to $0.8 million
for the three months ended March 31, 2009. The increases in 2010 were due mainly to higher employee
expenses including severance charges, professional fees for legal and auditing services, employee
recruitment costs and stock based compensation expense.
Interest income for the three months ended March 31, 2010 was $5 thousand compared to $33 thousand
for the three months ended March 31, 2009 due to lower interest rates earned on our marketable
securities in 2010 as compared to 2009.
Other for the three months ended March 31, 2010 was $19 thousand in expense compared to $24
thousand in income for the three months ended March 31, 2009. The expense in 2010 is due to a
foreign exchange loss, while income earned in 2009 related to gains on sales of equipment.
Liquidity and Capital Resources
OncoGenex has incurred an accumulated deficit of $56.5 million through March 31, 2010, and we
expect to incur substantial and increasing additional losses in the future as we expand our
research and development activities. We have not generated any revenue from product sales to date,
and we do not expect to generate product sales revenue for several years, if ever. In the three
month period ended March 31, 2010, we generated $4.7 million in collaboration revenue from the Teva
Collaboration Agreement.
All of our operations to date have been funded through the sale of our debt and equity securities,
and upfront payments received from Teva. As at March 31, 2010, OncoGenex had cash, cash
equivalents, and short-term investments of $47.6 million in the aggregate as compared to cash,
cash equivalents and short-term investments of $64.6 million as at December 31, 2009. As at March
31, 2010, OncoGenex does not have any borrowing or credit facilities available to it. Based upon
our current expectations, we believe our capital resources at March 31, 2010 will be sufficient to
fund our currently planned operations into 2012 and expect that both planned phase 3 prostate
cancer trials will be fully accrued by this time. Our currently planned operations are set forth
below under the heading Operating Capital and Capital Expenditure Requirements.
Cash Flows
Cash Used in Operations
For the three months ended March 31, 2010, net cash used in operations was $17.1 million, compared
to $3.0 million in the corresponding period of 2009. This increase in cash used in operations in
the three months ended March 31, 2010 compared to the same period in 2009 was primarily
attributable to increased R&D expenses associated with manufacturing of OGX-011 drug product, as
well as upfront payments for OGX-011 clinical trial activities.
Cash Provided by Financing Activities
For the three months ended March 31, 2010, net cash provided by financing activities was $185
thousand as compared to $23 thousand in the corresponding period of 2009. All net cash provided by
financing activities in the three months ended March 31, 2010 and March 31, 2009 was the result of
proceeds from the issuance of common shares on stock option exercises.
23
Cash Used/Provided by Investing Activities
Net cash provided by investing activities for the three months ended March 31, 2010 was $379
thousand as compared to $4.8 million in the corresponding period of 2009. Net cash provided by
investing activities in the three months ended March 31, 2010 and 2009 was due to transactions
involving marketable securities in the normal course of business. The related maturities and sales
of those investments provide working capital on an as-needed basis.
Operating Capital and Capital Expenditure Requirements
We believe that our cash, cash equivalents and short-term investments will be sufficient to fund
our currently planned operations into 2012, including:
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completing patient accrual in the SATURN trial, a phase 3 clinical trial evaluating a
durable pain palliation benefit for OGX-011 in combination with docetaxel as second-line
chemotherapy in approximately 300 men with CRPC, which we expect to initiate in the
second quarter of 2010; |
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completing patient accrual in a phase 3 clinical trial evaluating a survival benefit
for OGX-011 in combination with docetaxel as first-line chemotherapy in approximately 800
men with CRPC, expected to initiate in the third quarter of 2010; |
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completing follow-up monitoring visits related to our 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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initiating an investigator-sponsored phase 2 clinical trial evaluating OGX-427
treatment in patients with prostate cancer; and |
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meeting working capital needs, capital expenditures and general corporate purposes. |
As of March 31, 2010, we have a remaining commitment to fund $24.6 million towards the three phase
3 trials of OGX-011, while Teva is required to fund all additional expenses under the Clinical
Development Plan.
The final results from the phase 3 trials may be released at a date beyond our current available
cash runway. In addition, if we desire to conduct development activities with respect to our other
product candidates beyond those development activities mentioned in the list above, we will
require additional funding to support such operations. If and when needed to extend our cash
availability or to conduct any such currently unplanned development activities, we would seek any
such necessary funding through the licensing or sale of certain of our product candidates,
executing a partnership or collaboration agreement, or through private or public offerings of our
equity securities or debt financings.
24
Our future capital requirements will depend on many factors, including:
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maintaining our relationship with Teva and Tevas ongoing level of focus and efforts
to develop OGX-011; |
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our ability to obtain additional funding through a partnership or collaboration
agreement with a third party or licenses 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. |
Off-Balance Sheet Arrangements
We do not have any off-balance sheet financing arrangements at March 31, 2010.
Inflation
We do 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, 2009, as filed with the SEC on March 8, 2010. 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 2009 Form 10-K. For more information
regarding our current contingencies and commitments, see note 7 to the financial statements
included above, which is incorporated by reference herein.
Material Changes in Financial Condition
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March 31, |
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December 31, |
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(In thousands) |
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2010 |
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2009 |
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$ |
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$ |
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Total assets |
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56,438 |
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68,980 |
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Total liabilities |
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36,169 |
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46,021 |
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Shareholders equity |
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20,269 |
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22,959 |
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The decrease in assets from December 31, 2009 primarily relates to decreased cash, cash equivalents
and marketable securities as these assets have been used to fund operations, and payments in 2010
of milestone amounts owing to Isis and UBC included in accounts payable at year end. The decrease
in liabilities from December 31, 2009 relates predominantly to the payment in 2010 of milestone
amounts owing to Isis and UBC included in accounts payable at year end, the amortization of
restructuring related liabilities, and the recognition of deferred collaboration revenue, offset by
increased payables manufacturing costs and clinical trial costs payable relating to the OGX-011
Clinical Development Plan.
25
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 2009 Form 10-K filed with the SEC on march 8, 2010. Since the date of our 2009
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 2, Accounting Policies, of the consolidated financial statements for information related
to the adoption of new accounting standards in the 2010 first quarter, 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.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Interest Rate Risk
We invest our cash in a variety of financial instruments, primarily in short-term bank deposits,
money market funds, and domestic and foreign commercial paper and government securities. These
investments are denominated in U.S. dollars and are subject to interest rate risk, and could
decline in value if interest rates fluctuate. Our investment portfolio includes only marketable
securities with active secondary or resale markets to help ensure portfolio liquidity. Due to the
conservative nature of these instruments, we do not believe that we have a material exposure to
interest rate risk. For example, if market rates hypothetically increase immediately and uniformly
by 100 basis points from levels at March 31, 2010, the decline in the fair value of our investment
portfolio would not be material.
Foreign Currency Exchange Risk
We are exposed to risks associated with foreign currency transactions on certain contracts and
payroll expenses related to our Canadian subsidiary, OncoGenex Technologies, denominated in
Canadian dollars and we have not hedged these amounts. As our unhedged foreign currency
transactions fluctuate, our earnings might be negatively affected. Accordingly, changes in the
value of the U.S. dollar relative to the Canadian dollar might have an adverse effect on our
reported results of operations and financial condition, and fluctuations in exchange rates might
harm our reported results and accounts from period to period.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
The Company maintains disclosure controls and procedures that are designed to ensure that material
information required to be disclosed in the Companys periodic reports filed or submitted under the
Securities Exchange Act of 1934, as amended (the Exchange Act), is recorded, processed,
summarized and reported within the time periods specified in the SECs rules and forms. The
Companys disclosure controls and procedures are also designed to ensure that information required
to be disclosed in the reports the Company files or submits under the Exchange Act is accumulated
and communicated to the Companys management, including its principal executive officer and
principal financial officer as appropriate, to allow timely decisions regarding required
disclosure.
During the quarter ended March 31, 2010, the Company carried out an evaluation, under the
supervision and with the participation of the Companys management, including the chief executive
officer and the chief financial officer, of the effectiveness of the design and operation of the
disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange
Act. Based upon that
evaluation, the Companys chief executive officer and chief financial officer concluded that the
Companys disclosure controls and procedures were effective, as of the end of the period covered by
this report.
Changes in Internal Control Over Financial Reporting
The Company has not made any changes to our internal control over financial reporting (as defined
in Rule 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended March 31, 2010
that have materially affected, or are reasonably likely to materially affect, the Companys
internal control over financial reporting.
26
PART II. OTHER INFORMATION
Item 1A. Risk Factors
In
addition to the other information set forth in this Quarterly Report
on Form 10-Q/A, 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, 2009, as filed with the SEC on March 8, 2010, 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 6. Exhibits
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.
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ONCOGENEX PHARMACEUTICALS, INC.
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Date: May 7, 2010 |
By: |
/s/ Cameron Lawrence
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Cameron Lawrence |
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Principal Financial Officer
(Principal Financial and Accounting Officer) |
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27
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Exhibit |
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Number |
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Description |
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2.1 |
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Arrangement Agreement between the Company and OncoGenex
Technologies Inc. dated May 27, 2008 (Incorporated by
reference to the Companys proxy statement on Schedule 14A
filed on July 3, 2008.) |
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2.2 |
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First Amendment to Arrangement Agreement between the
Company and OncoGenex Technologies Inc. dated August 11,
2008 (Incorporated by reference to the Companys quarterly
report on Form 10-Q for the quarter ended September 30,
2008.) |
|
|
|
|
|
|
2.3 |
|
|
Second Amendment to Arrangement Agreement between the
Company and OncoGenex Technologies Inc. dated August 15,
2008 (Incorporated by reference to the Companys quarterly
report on Form 10-Q for the quarter ended September 30,
2008.) |
|
|
|
|
|
|
3.1 |
|
|
Amended and Restated Certificate of Incorporation (As
Amended Through October 17, 1995) (Incorporated by
reference to the Companys Registration Statement on Form
S-1, Reg. No. 33-96112.) |
|
|
|
|
|
|
3.2 |
|
|
Certificate of Amendment to Certificate of Incorporation
filed on May 6, 1999 (Incorporated by reference to
Companys quarterly report on Form 10-Q for the quarter
ended March 31, 1999.) |
|
|
|
|
|
|
3.3 |
|
|
Certificate of Correction filed on March 9, 2009 to
Certificate of Amendment filed on May 6, 1999
(Incorporated by reference to the Companys current report
on Form 8-K filed on March 11, 2009.) |
|
|
|
|
|
|
3.4 |
|
|
Certificate of Amendment to Certificate of Incorporation
filed on May 7, 2004 (Incorporated by reference to the
Companys annual report on Form 10-K for the year ended
December 31, 2008.) |
|
|
|
|
|
|
3.5 |
|
|
Certificate of Correction filed on March 9, 2009 to
Certificate of Amendment filed on May 7, 2004
(Incorporated by reference to the Companys current report
on Form 8-K filed on March 11, 2009.) |
|
|
|
|
|
|
3.6 |
|
|
Certificate of Amendment to Certificate of Incorporation
of Sonus Pharmaceuticals Inc., effective August 20, 2008
(Incorporated by reference to the Companys quarterly
report on Form 10-Q for the quarter ended September 30,
2008.) |
|
|
|
|
|
|
3.7 |
|
|
Third Amended and Restated Bylaws of Oncogenex
Pharmaceuticals, Inc. (Incorporated by reference to the
Companys current report on Form 8-K filed on October 30,
2008.) |
|
|
|
|
|
|
4.1 |
|
|
Specimen Certificate of Common Stock (Incorporated by
reference to the Companys quarterly report on Form 10-Q
for the quarter ended September 30, 2008.) |
|
|
|
|
|
|
4.2 |
|
|
Amended and Restated Rights Agreement dated as of July 24,
2002 between Sonus Pharmaceuticals Inc. and U.S. Stock
Transfer Corporation (Incorporated by reference to the
Companys amended Form 8-A filed on July 25, 2002.) |
|
|
|
|
|
|
4.3 |
|
|
First Amendment to Amended and Restated Rights Agreement
dated as of October 17, 2005 between Sonus Pharmaceuticals
Inc. and U.S. Stock Transfer Corporation (Incorporated by
reference to the Companys amended Form 8-A filed on
October 18, 2005.) |
28
|
|
|
|
|
Exhibit |
|
|
Number |
|
Description |
|
|
|
|
|
|
4.4 |
|
|
Second Amendment to Amended and Restated Rights Agreement
dated as of August 10, 2006 between Sonus Pharmaceuticals
Inc. and U.S. Stock Transfer Corporation (Incorporated by
reference to the Companys amended Form 8-A filed on
August 14, 2006.) |
|
|
|
|
|
|
4.5 |
|
|
Third Amendment to Amended and Restated Rights Agreement
dated May 27, 2008 between Sonus Pharmaceuticals Inc. and
Computershare Trust Company, N.A. (Incorporated by
reference to the Companys current report on Form 8-K
filed on May 30, 2008.) |
|
|
|
|
|
|
4.6 |
|
|
Form of Escrow Agreement between the Company,
Computershare Trust Company of Canada and former
shareholders and debentureholders of OncoGenex
Technologies Inc. (Incorporated by reference to the
Companys proxy statement on Schedule 14A filed on July 3,
2008.) |
|
|
|
|
|
|
4.7 |
|
|
Form of OncoGenex Voting Agreement (Incorporated by
reference to the Companys proxy statement on Schedule 14A
filed on July 3, 2008.) |
|
|
|
|
|
|
4.8 |
|
|
Form of Sonus Voting Agreement (Incorporated by reference
to the Companys proxy statement on Schedule 14A filed on
July 3, 2008.) |
|
|
|
|
|
|
10.1 |
|
|
Sonus Pharmaceuticals, Inc. Incentive Stock Option,
Nonqualified Stock Option and Restricted Stock Purchase
Plan 1991 (the 1991 Plan), as amended (Incorporated by
reference to the Companys Registration Statement on Form
S-1, Reg. No. 33-96112.) |
|
|
|
|
|
|
10.2 |
|
|
Form of Incentive Option Agreement (pertaining to the 1991
Plan) (Incorporated by reference to the Companys
Registration Statement on Form S-1, Reg. No. 33-96112.) |
|
|
|
|
|
|
10.3 |
|
|
Form of Sonus Pharmaceuticals, Inc. Nonqualified Stock
Option Agreement under the 1991 Plan (Incorporated by
reference to the Companys Registration Statement on Form
S-1, Reg. No. 33-96112.) |
|
|
|
|
|
|
10.4 |
|
|
Sonus Pharmaceuticals, Inc. 1999 Nonqualified Stock
Incentive Plan (the 1999 Plan) (Incorporated by
reference to Companys quarterly report on Form 10-Q for
the quarter ended March 31, 1999.) |
|
|
|
|
|
|
10.5 |
|
|
Form of Sonus Pharmaceuticals, Inc. Nonqualified Stock
Option Agreement under the 1999 Plan (Incorporated by
reference to Companys quarterly report on Form 10-Q for
the quarter ended March 31, 1999.) |
|
|
|
|
|
|
10.6 |
|
|
Form of Sonus Pharmaceuticals, Inc. Restricted Stock
Purchase Agreement under the 1999 Plan (Incorporated by
reference to Companys quarterly report on Form 10-Q for
the quarter ended March 31, 1999.) |
|
|
|
|
|
|
10.7 |
|
|
Sonus Pharmaceuticals, Inc. 2000 Stock Incentive Plan (the
2000 Plan) (Incorporated by reference to the Companys
quarterly report on Form 10-Q for the quarter ended
June 30, 2000.) |
|
|
|
|
|
|
10.8 |
|
|
First Amendment to Sonus Pharmaceuticals, Inc. 2000 Plan
(Incorporated by reference to the Companys quarterly
report on Form 10-Q for the quarter ended September 30,
2006.) |
29
|
|
|
|
|
Exhibit |
|
|
Number |
|
Description |
|
|
|
|
|
|
10.9 |
|
|
Form of Sonus Pharmaceuticals, Inc. Stock Option Agreement
(pertaining to the 2000 Plan) (Incorporated by reference
to the Companys quarterly report on Form 10-Q for the
quarter ended June 30, 2000.) |
|
|
|
|
|
|
10.10 |
|
|
Sonus Pharmaceuticals, Inc. 2007 Performance Incentive
Plan (the 2007 Plan) (Incorporated by reference to the
Companys proxy statement on Schedule 14A filed on
April 3, 2007.) |
|
|
|
|
|
|
10.11 |
|
|
Form of Sonus Pharmaceuticals, Inc. Stock Option Agreement
(pertaining to the 2007 Plan) (Incorporated by reference
to the Companys quarterly report on Form 10-Q for the
quarter ended September 30, 2007.) |
|
|
|
|
|
|
10.12 |
|
|
Form of Sonus Pharmaceuticals, Inc. Restricted Stock
Purchase Agreement under the 2007 Plan (Incorporated by
reference to the Companys quarterly report on Form 10-Q
for the quarter ended September 30, 2007.) |
|
|
|
|
|
|
10.13 |
|
|
OncoGenex Technologies Inc. Amended and Restated Stock
Option Plan (Incorporated by reference to the OncoGenex
Technologies Inc. registration statement on Form F-1 filed
on December 13, 2006.) |
|
|
|
|
|
|
10.14 |
|
|
Stock Option Assumption, Amending and Confirmation
Agreement dated as of August 21, 2008 between the Company
and OncoGenex Technologies Inc. (Incorporated by reference
to the Companys registration statement on Form S-8 filed
on August 26, 2008.) |
|
|
|
|
|
|
10.15 |
|
|
OncoGenex Pharmaceuticals, Inc. Short Term Incentive
Awards Program (Incorporated by reference to the Companys
current report on Form 8-K filed on April 2, 2009.) |
|
|
|
|
|
|
10.16 |
|
|
Agreement and Consent Form (related to the Short Term
Incentive Awards Program) (Incorporated by reference to
the Companys current report on Form 8-K filed on April 2,
2009.) |
|
|
|
|
|
|
10.17 |
|
|
Form of Indemnification Agreement for Officers and
Directors of the Company (Incorporated by reference to the
Companys Registration Statement on Form S-1, Reg.
No. 33-96112.) |
|
|
|
|
|
|
10.18 |
|
|
Form of Indemnification Agreement between OncoGenex
Technologies Inc. and each of Scott Cormack, Stephen
Anderson and Cindy Jacobs (Incorporated by reference to
the OncoGenex Technologies Inc. registration statement on
Form F-1 filed on December 13, 2006.) |
|
|
|
|
|
|
10.19 |
|
|
Form of Indemnification Agreement between OncoGenex
Technologies Inc. and Neil Clendeninn (Incorporated by
reference to the OncoGenex Technologies Inc. registration
statement on Form F-1 filed on December 13, 2006.) |
|
|
|
|
|
|
10.20 |
|
|
Executive Termination Agreement and General Release dated
August 21, 2008 between the Company and Michael Martino
(Incorporated by reference to the Companys quarterly
report on Form 10-Q for the quarter ended September 30,
2008.) |
30
|
|
|
|
|
Exhibit |
|
|
Number |
|
Description |
|
|
|
|
|
|
10.21 |
|
|
Executive Termination Agreement and General Release dated
August 21, 2008 between the Company and Alan Fuhrman
(Incorporated by reference to the Companys quarterly
report on Form 10-Q for the quarter ended September 30,
2008.) |
|
|
|
|
|
|
10.22 |
|
|
Employment Agreement between OncoGenex Technologies Inc.
and the Company and Scott Cormack dated as of November 4,
2009 (Incorporated by reference to the Companys quarterly
report on Form 10-Q for the quarter ended September 30,
2009.) |
|
|
|
|
|
|
10.23 |
|
|
Employment Agreement between OncoGenex Technologies Inc.
and the Company and Stephen Anderson dated as of
November 4, 2009 (Incorporated by reference to the
Companys quarterly report on Form 10-Q for the quarter
ended September 30, 2009.) |
|
|
|
|
|
|
10.24 |
|
|
Amendment dated February 24, 2010 to the Employment
Agreement between OncoGenex Technologies Inc. and Stephen
Anderson (Incorporated by reference to the Companys
current report on Form 8-K filed February 25, 2010.) |
|
|
|
|
|
|
10.25 |
|
|
Employment Agreement between the Company and Cindy Jacobs
dated as of November 3, 2009 (Incorporated by reference to
the Companys quarterly report on Form 10-Q for the
quarter ended September 30, 2009.) |
|
|
|
|
|
|
10.26 |
|
|
Employment Agreement dated October 14, 2008 between
OncoGenex Technologies Inc. and Cameron Lawrence
(Incorporated by reference to the Companys current report
on Form 8-K filed March 1, 2010.) |
|
|
|
|
|
|
10.27 |
|
|
Employment Amending Agreement dated January 1, 2009
between OncoGenex Technologies Inc. and Cameron Lawrence
(Incorporated by reference to the Companys current report
on Form 8-K filed March 1, 2010.) |
|
|
|
|
|
|
10.28 |
|
|
Securities Purchase Agreement dated as of August 15, 2005
by and among Sonus Pharmaceuticals Inc. and the investors
named therein (Incorporated by reference to the Companys
current report on Form 8-K filed on August 18, 2005.) |
|
|
|
|
|
|
10.29 |
|
|
Form of Purchase Warrant related to the Securities
Purchase Agreement (Incorporated by reference to the
Companys current report on Form 8-K filed on August 18,
2005.) |
|
|
|
|
|
|
10.30 |
|
|
Form of Purchase Warrant issued to Schering AG
(Incorporated by reference to the Schedule 13D filed by
Schering Berlin Venture Corporation on October 31, 2005.) |
|
|
|
|
|
|
10.31 |
|
|
Registration Rights Agreement dated as of August 15, 2005
by and among Sonus Pharmaceuticals Inc. and the investors
named therein (Incorporated by reference to the Companys
current report on Form 8-K filed on August 18, 2005.) |
|
|
|
|
|
|
10.32 |
|
|
Lease by and between BMR-217th Place LLC and
the Company dated as of November 21, 2006 (Incorporated by
reference to the Companys annual report on Form 10-K for
the year ended December 31, 2006.) |
|
|
|
|
|
|
10.33 |
|
|
First Amendment to Lease by and between
BMR-217th Place LLC and the Company dated as of
August 17, 2007 (Incorporated by reference to the
Companys annual report on Form 10-K for the year ended
December 31, 2007.) |
|
|
|
|
|
|
10.34 |
|
|
Second Amendment to Lease by and between
BMR-217th Place LLC and the Company dated as of
January 28, 2008 (Incorporated by reference to the
Companys quarterly report on Form 10-Q for the quarter
ended March 31, 2008.) |
31
|
|
|
|
|
Exhibit |
|
|
Number |
|
Description |
|
|
|
|
|
|
10.35 |
|
|
Amended and Restated License Agreement effective as of
July 2, 2008 by and between OncoGenex Technologies Inc.
and Isis Pharmaceuticals, Inc. (OGX-011)* (Incorporated by
reference to the Companys annual report on Form 10-K for
the year ended December 31, 2008.) |
|
|
|
|
|
|
10.36 |
|
|
Letter Agreement Regarding Certain Sublicense
Consideration for OGX-011 between OncoGenex Technologies
Inc. and Isis Pharmaceuticals, Inc. dated December 18,
2009 (Incorporated by reference to the Companys annual
report on Form 10-K for the year ended December 31, 2009.) |
|
|
|
|
|
|
10.37 |
|
|
Amendment No. 1 to Amended and Restated License Agreement
between OncoGenex Technologies Inc. and Isis
Pharmaceuticals, Inc. dated December 19, 2009 (OGX-011)*
(Incorporated by reference to the Companys annual report
on Form 10-K for the year ended December 31, 2009.) |
|
|
|
|
|
|
10.38 |
|
|
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)* (Incorporated by reference to
the OncoGenex Technologies Inc. registration statement on
Form F-1, Amendment No. 1, filed on January 29, 2007.) |
|
|
|
|
|
|
10.39 |
|
|
Second Amending Agreement and Consent as of August 7, 2008
between the University of British Columbia and OncoGenex
Technologies Inc. (OGX-011) (Incorporated by reference to
the Companys quarterly report on Form 10-Q for the
quarter ended September 30, 2008.) |
|
|
|
|
|
|
10.40 |
|
|
Third Amending Agreement to the License Agreement between
OncoGenex Technologies Inc and the University of British
Columbia dated as of December 20, 2009 (OGX-011)*
(Incorporated by reference to the Companys annual report
on Form 10-K for the year ended December 31, 2009.) |
|
|
|
|
|
|
10.41 |
|
|
Collaboration and License Agreement between OncoGenex
Technologies Inc. and Isis Pharmaceuticals, Inc. effective
as of January 5, 2005 (OGX-427)* (Incorporated by
reference to the OncoGenex Technologies Inc. registration
statement on Form F-1, Amendment No. 1, filed on
January 29, 2007.) |
|
|
|
|
|
|
10.42 |
|
|
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)* (Incorporated by reference to
the OncoGenex Technologies Inc. registration statement on
Form F-1, Amendment No. 1, filed on January 29, 2007.) |
|
|
|
|
|
|
10.43 |
|
|
Second Amending Agreement as of August 7, 2008 between the
University of British Columbia and OncoGenex Technologies
Inc. (OGX-427) (Incorporated by reference to the Companys
quarterly report on Form 10-Q for the quarter ended
September 30, 2008.) |
|
|
|
|
|
|
10.44 |
|
|
Collaboration and License Agreement between OncoGenex
Technologies Inc. and Teva Pharmaceutical Industries Ltd.
dated as of December 20, 2009 (OGX-011)* (Incorporated by
reference to the Companys annual report on Form 10-K for
the year ended December 31, 2009.) |
32
|
|
|
|
|
Exhibit |
|
|
Number |
|
Description |
|
|
|
|
|
|
31.1 |
|
|
Certification of President and Chief Executive Officer
pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities
Exchange Act of 1934, as adopted pursuant to Section 302
of the Sarbanes-Oxley Act of 2002 |
|
|
|
|
|
|
31.2 |
|
|
Certification of Chief Financial Officer pursuant to
Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act
of 1934, as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002 |
|
|
|
|
|
|
32.1 |
|
|
Certification of President and Chief Executive Officer
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
|
|
|
32.2 |
|
|
Certification of Chief Financial Officer pursuant to 18
U.S.C. Section 1350, as adopted pursuant to Section 906 of
the Sarbanes-Oxley Act of 2002 |
|
|
|
|
|
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. |
33