Exhibit 99.1

 

OncoGenex Pharmaceuticals, Inc. Reports Financial Results for Third Quarter 2016

 

 

BOTHELL, WA, and VANCOUVER, British Columbia, Nov. 10, 2016 – OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced its third quarter 2016 financial results.  

 

Recent Events

 

In November 2016, the company announced positive survival results from the final analysis of the Phase 2 Borealis-2™ trial of apatorsen in combination with docetaxel treatment that enrolled 200 patients with metastatic bladder cancer whose disease had progressed following first-line platinum-based chemotherapy.  The company does not currently intend to fund further development of apatorsen in bladder cancer without a collaboration partner.  

 

Also in November 2016, OncoGenex discontinued the development of its custirsen program after the  AFFINITY and ENSPIRIT Phase 3 clinical trials failed to meet their primary endpoints. 

Financial Results

As of September 30, 2016, the company’s cash, cash equivalents, and short-term investments were $32.5 million compared with $55.2 million as of December 31, 2015. Based on current expectations, OncoGenex believes that its cash, cash equivalents, and short-term investments will be sufficient to fund its currently planned operations for at least the next 12 months.

 

Revenue for the three and nine months ended September 30, 2016 decreased to zero and $5.1 million, respectively, from $6.7 million and $12.1 million for the three and nine months ended September 30, 2015, respectively. The advanced reimbursement payment made by Teva, as part of the Termination Agreement, was deferred and recognized as collaboration revenue on a dollar for dollar basis as costs were incurred as part of the continuing research and development activities related to custirsen. The decrease in collaboration revenue in 2016 as compared to 2015 was due to the full recognition of the remaining amounts of deferred revenue in 2016.

 

Total operating expenses for the three and nine months ended September 30, 2016 were $4.4 million and $20.2 million, respectively, compared to $11.4 million and $27.4 million for the three and nine months ended September 30, 2015, respectively.

 

Net loss for the three and nine months ended September 30, 2016 was $3.7 million and $14.3 million, respectively, compared to $4.6 million and $15.1 million for the three and nine months ended September 30, 2015, respectively.

 

As of November 10, 2016 OncoGenex had 30,020,294 shares outstanding.

 

OncoGenex is continuing work with MTS Health Partners in the exploration of strategic alternatives as announced in mid-August.

 

About OncoGenex and Apatorsen

OncoGenex is a biopharmaceutical company committed to the development and commercialization of new therapies that address treatment resistance in cancer patients. The company’s lead compound,


apatorsen (OGX-427), is designed to inhibit production of Hsp27, disable cancer cells' defenses and overcome treatment resistance. Hsp27 is an intracellular protein that protects cancer cells by helping them survive, leading to resistance and more aggressive cancer phenotypes. Both the potential single-agent activity and synergistic activity of apatorsen with cancer treatments may increase the overall benefit of existing therapies and augment the durability of treatment outcomes, which could lead to increased patient survival. 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 regarding the potential benefits and potential development of our product candidates, clinical development plans and business strategies. 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 of failure or delays in our ongoing and future clinical trials, the risk that any of our product candidates will receive regulatory approval or will be successfully commercialized, the risk that new developments in the rapidly evolving cancer therapy landscape require changes in our business strategy or clinical trial plans, or limit the potential benefits of our product candidates, the risk that we are unable to raise on acceptable terms the capital needed to complete our clinical trials, the risk that our product candidates do not demonstrate the hypothesized or expected benefits 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.

 

Borealis-2™ is a registered trademark of OncoGenex Pharmaceuticals, Inc.

 

OncoGenex Contact:

Jim DeNike

jdenike@oncogenex.com

(425) 686-1514

 

 

 

 

 

 

 

 

 

 

 


 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Consolidated Statements of Loss

 

(In thousands, except per share and share data)

 

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three months ended September 30,

 

 

Nine months ended September 30,

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Collaboration revenue

$

-

 

 

$

6,737

 

 

$

5,062

 

 

$

12,136

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  Research and development

 

3,782

 

 

 

8,303

 

 

 

13,086

 

 

 

18,520

 

  General and administrative

 

1,864

 

 

 

3,125

 

 

 

6,638

 

 

 

8,890

 

  Restructuring costs (recovery)

 

(31

)

 

 

-

 

 

 

392

 

 

 

-

 

  Recovery of lease termination loss

 

(1,250

)

 

 

-

 

 

 

(1,250

)

 

 

-

 

  Litigation settlement loss

 

-

 

 

 

-

 

 

 

1,375

 

 

 

-

 

    Total operating expenses

 

4,365

 

 

 

11,428

 

 

 

20,241

 

 

 

27,410

 

Loss from operations

 

(4,365

)

 

 

(4,691

)

 

 

(15,179

)

 

 

(15,274

)

  Other income (expense)

 

675

 

 

 

141

 

 

 

893

 

 

 

197

 

Net loss

$

(3,690

)

 

$

(4,550

)

 

$

(14,286

)

 

$

(15,077

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per share

$

(0.12

)

 

$

(0.16

)

 

$

(0.48

)

 

$

(0.60

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average number of basic and diluted common shares

 

30,013,928

 

 

 

28,538,918

 

 

 

29,925,219

 

 

 

24,914,844

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Consolidated Balance Sheets

 

(In thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

September 30,

 

 

December 31,

 

 

 

 

 

 

 

 

 

 

2016

 

 

2015

 

 

 

 

 

 

 

 

 

 

(unaudited)

 

 

 

 

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  Cash, cash equivalents, short term investments and restricted cash

 

 

 

 

 

 

 

 

$

32,727

 

 

$

55,458

 

  Interest receivable

 

 

 

 

 

 

 

 

 

36

 

 

 

111

 

  Prepaid expenses and other current assets

 

 

 

 

 

 

 

 

 

1,805

 

 

 

2,001

 

  Property, equipment and other assets

 

 

 

 

 

 

 

 

 

506

 

 

 

639

 

Total assets

 

 

 

 

 

 

 

 

$

35,074

 

 

$

58,209

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities and stockholders' equity:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  Accounts payable and accrued liabilities

 

 

 

 

 

 

 

 

$

10,181

 

 

$

13,217

 

  Current portion of long-tem obligations

 

 

 

 

 

 

 

 

 

57

 

 

 

52

 

  Warrant liability

 

 

 

 

 

 

 

 

 

350

 

 

 

1,105

 

  Lease termination liability

 

 

 

 

 

 

 

 

 

-

 

 

 

1,250

 

  Deferred collaboration revenue

 

 

 

 

 

 

 

 

 

-

 

 

 

5,040

 

  Long term liabilities

 

 

 

 

 

 

 

 

 

67

 

 

 

105

 

  Stockholders' equity

 

 

 

 

 

 

 

 

 

24,419

 

 

 

37,440

 

Total liabilities and stockholders' equity

 

 

 

 

 

 

 

 

$

35,074

 

 

$

58,209