8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 11, 2014

ONCOGENEX PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Delaware	033-80623	95-4343413
(State or other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)

1522 217th Place S.E. Bothell, Washington	98021
(Address of Principal Executive Offices)	(Zip Code)

Registrant’s telephone number, including area code: (425) 487-9500

N/A

(Former name or former address if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 2.02 Results of Operations and Financial Condition.

On March 11, 2014, OncoGenex Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the fourth quarter and year ended December 31, 2013. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
99.1	Press release of OncoGenex Pharmaceuticals, Inc. dated March 11, 2014

The information in Item 2.02 of this Form 8-K and Exhibit 99.1 attached hereto is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

	ONCOGENEX PHARMACEUTICALS, INC.
Date: March 11, 2014	/s/ Susan Wyrick
	Susan Wyrick Vice President, Finance (Principal Accounting Officer)

EXHIBIT INDEX

Exhibit No.	Description
99.1	Press release of OncoGenex Pharmaceuticals, Inc. dated March 11, 2014

EX-99.1

Exhibit 99.1

OncoGenex Pharmaceuticals, Inc. Reports Financial Results for Fourth Quarter and Year End 2013

Conference call to be held on Tuesday, March 11, 2014 at 4:30 p.m. Eastern Time

BOTHELL, WA, and VANCOUVER, British Columbia, March 11, 2014 – OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today provided a summary of clinical developments and anticipated near-term milestones and announced fourth quarter and year end 2013 financial results.

Clinical Developments and Anticipated Near-term Milestones

• Custirsen

• The SYNERGY Phase 3 trial is designed to evaluate a survival benefit for custirsen, in combination with first-line docetaxel chemotherapy, in men with metastatic castrate-resistant prostate cancer, or CRPC. OncoGenex recently announced that the pre-specified number of events required for final analysis of the Phase 3 SYNERGY trial were reached. Overall survival results will remain blinded until all study data have been thoroughly reviewed and prepared for final analysis, and final results are expected by mid-year 2014.

• The AFFINITY Phase 3 trial is designed to evaluate a survival benefit for custirsen in combination with cabazitaxel treatment as second-line chemotherapy in patients with CRPC. Enrollment of approximately 630 patients is ongoing and expected to be completed by the end of 2014.

• The ENSPIRIT Phase 3 trial is evaluating a survival benefit for custirsen in combination with docetaxel treatment as second-line chemotherapy in patients with non-small cell lung cancer (NSCLC). Enrollment of approximately 1,100 patients is ongoing.

• Apatorsen

• OncoGenex and collaborating investigators are in the process of conducting seven randomized Phase 2 clinical trials to evaluate apatorsen’s ability to inhibit Heat shock protein 27 (Hsp27) and improve treatment outcomes in bladder, lung, pancreatic and prostate cancer patients. Patient enrollment in the Borealis-1™ Phase 2 trial of apatorsen in combination with gemcitabine and cisplatin in patients with metastatic bladder cancer was fully enrolled in July 2013 and data are expected to be available in the second half of 2014.

Financial Update and Results

• Revenue for the fourth quarter and year ended December 31, 2013 was $8.6 million and $29.9 million, respectively. This compares with $9.8 million and $20.1 million, respectively, in the same periods in 2012. Revenue earned in 2013 consists of reimbursable clinical trial, manufacturing and preclinical costs incurred by OncoGenex under the Amended Clinical Development Plan with Teva.

• The Company has fulfilled its obligation of funding $30.0 million towards the development of custirsen. Teva is required to fund all additional expenses under the Amended Clinical Development Plan.

• Total operating expenses for the fourth quarter and year ended December 31, 2013 were $15.6 million and $65.2 million, respectively, compared with $16.0 million and $46.1 million,

respectively, in the same periods in 2012. The increase in 2013 as compared to 2012 was predominantly the result of higher clinical trial expenses associated with patient enrollment and treatment in the AFFINITY and Borealis-1 trials, increased costs related to our investigator-sponsored apatorsen trials, toxicology expenses related to apatorsen and OGX-225 and increased employee expenses, including stock-based compensation, due to an increase in the average number of employees to support our clinical development activities.

• Net loss for the fourth quarter and year ended December 31, 2013 was $6.7 million, or $0.45 per diluted common share, and $31.8 million, or $2.17 per diluted common share, respectively. Comparatively, net loss for the fourth quarter and year ended December 31, 2012 was $4.1 million, or $0.28 per diluted common share, and $21.1 million, or $1.56 per diluted common share, respectively.

• The company had $39.2 million in cash, cash equivalents and short-term investments as of December 31, 2013, compared to $75.4 million as of December 31, 2012.

• Based on current expectations, the company believes its capital resources as of December 31, 2013 will be sufficient to fund its currently-planned operations beyond the first quarter of 2015, and through:

• the expected release of final survival results from the SYNERGY trial by mid-2014;

• the expected release of final survival results from the Borealis-1 trial in the second-half of 2014; and

• the completion of enrollment in the AFFINITY and Spruce trials by the end of 2014.

• At March 11, 2014, OncoGenex had 14,718,610 shares outstanding.

Consolidated Statements of Loss

(In thousands, except per share and share data)

	Three months ended December 31,						Twelve months ended December 31,
	2013			2012			2013			2012
Collaboration revenue	$	8,604		$	9,780		$	29,882		$	20,095
Operating expenses:
Research and development		13,195			15,645			55,317			39,948
General and administrative		2,446			2,042			9,892			7,791
Restructuring gain		—			(1,657	)		—			(1,657	)
Total operating expenses		15,641			16,030			65,209			46,082
Loss from operations		(7,037	)		(6,250	)		(35,327	)		(25,987	)
Other income		359			2,147			3,478			4,889
Net loss	$	(6,678	)	$	(4,103	)	$	(31,849	)	$	(21,098	)
Basic and diluted net loss per share	$	(0.45	)	$	(0.28	)	$	(2.17	)	$	(1.56	)
Weighted average number of basic and diluted common shares		14,707,558			14,656,793			14,683,389			13,522,723

Consolidated Balance Sheets

(In thousands)

	December 31, 2013		December 31, 2012
Assets:
Cash, cash equivalents, short term investments and restricted cash	$	39,536	$	75,697
Interest receivable		218		327
Amounts receivable		8,657		714
Prepaid expenses and other current assets		5,770		3,755
Property, equipment and other assets		1,508		1,523
Total assets	$	55,689	$	82,016
Liabilities and stockholders’ equity:
Accounts payable and accrued liabilities	$	13,628	$	7,050
Current portion of long-term obligations		1,092		1,084
Warrant liability		214		3,422
Long term liabilities		3,544		4,253
Stockholders’ equity		37,211		66,207
Total liabilities and stockholders’ equity	$	55,689	$	82,016

Conference Call Details

OncoGenex will host a conference call at 4:30 p.m. Eastern Time today, Tuesday, March 11, 2014, to provide a business update and discuss the fourth quarter and year end 2013 results. A live event will be available on the Investor Relations section of the OncoGenex Web site at www.OncoGenex.com. Alternatively, you may access the live conference call by dialing (877) 606-1416 (U.S. & Canada) or 707-287-9313 (International). A replay of the webcast will be available approximately two hours after the call and will be archived for 90 days.

About OncoGenex

OncoGenex is a biopharmaceutical company committed to the development and commercialization of new therapies that address treatment resistance in cancer patients. OncoGenex has a diverse oncology pipeline, with each product candidate having a distinct mechanism of action and representing a unique

opportunity for cancer drug development. OncoGenex and Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) have entered a global collaboration and license agreement to develop and commercialize OncoGenex’ lead drug candidate, custirsen. Custirsen is currently in Phase 3 clinical development as a treatment in men with metastatic castrate-resistant prostate cancer and in patients with advanced, unresectable non-small cell lung cancer. Apatorsen is currently being evaluated in seven randomized Phase 2 trials for a variety of cancers and OGX-225 is currently in pre-clinical development. More information is available at www.OncoGenex.com and at the company’s Twitter account: https://twitter.com/OncoGenex_IR.

OncoGenex’ Forward Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements concerning our anticipated product development activities, such as expected clinical trial completion and design, statements regarding the potential benefits and potential development of our product candidates and statements regarding our expected financial results and expected cash requirements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements. Such forward-looking statements are subject to risks and uncertainties, including, among others, the risk that our product candidates will not demonstrate the hypothesized or expected benefits, the risk of delays in our expected clinical trials, the risk that new developments in the rapidly evolving cancer therapy landscape require changes in our clinical trial plans or limit the potential benefits of our product, the risk that our cash resources are insufficient to fund our planned activities for the time period expected and the other factors described in our risk factors set forth in our filings with the Securities and Exchange Commission from time to time, including the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. The Company undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.

Media Contact:

Jaime Welch

jwelch@oncogenex.com

604-630-5403

Investor Relations Contact:

Susan Specht

sspecht@oncogenex.com

425-686-1535