Cascadian Therapeutics
Aug 8, 2016

Cascadian Therapeutics Reports Second Quarter 2016 Financial Results and Provides Corporate Update

Reported positive interim results from Phase 1b "Triplet" study investigating ONT-380 in combination with trastuzumab and capecitabine

Phase 2 "HER2CLIMB" study enrolling patients

SEATTLE, Aug. 08, 2016 (GLOBE NEWSWIRE) -- Cascadian Therapeutics (NASDAQ:CASC), a clinical-stage biopharmaceutical company, today provided a corporate update and reported financial results for the quarter ended June 30, 2016.

"During the second quarter, we continued to accelerate the clinical development of our lead product candidate ONT-380, a promising small molecule for the treatment of advanced, metastatic HER2+ breast cancer," said Scott Myers, President and CEO of Cascadian Therapeutics. "Early clinical results with ONT-380 when combined with T-DM1 or capecitabine have suggested a favorable safety and tolerability profile, systemic activity in advanced disease and the potential to improve outcomes in patients with and without brain metastases. We're looking forward to reporting new data from the ongoing Phase 1b Triplet study expected later this year. In addition, we were granted Fast Track designation from the FDA for ONT-380 in HER2+ metastatic breast cancer."

"Our continued progress and the refocusing of resources on development of ONT-380 and our Chk1 inhibitor, supported by a recent financing in June, leave us well-positioned to deliver on our business and clinical development plans," said Mr. Myers.

SECOND QUARTER AND RECENT HIGHLIGHTS

Clinical Development

Corporate Update

SECOND QUARTER 2016 FINANCIAL HIGHLIGHTS

Financial Guidance
Cascadian Therapeutics believes the following financial guidance to be correct as of the date provided. Cascadian Therapeutics is providing this guidance as a convenience to investors and assumes no obligation to update it.

Cascadian Therapeutics currently expects cash used in operations in 2016 to be approximately $38.0 million to $40.0 million.  With cash, cash equivalents and investments of $80.9 million as of June 30, 2016, Cascadian Therapeutics estimates that its cash, cash-equivalents and investments will be sufficient to fund operations for at least the next 12 months.

About Cascadian Therapeutics
Cascadian Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative product candidates for the treatment of cancer. Our lead product candidate, ONT-380, is an orally active and selective small molecule HER2 inhibitor, which has been studied in approximately 200 patients to date. Preliminary results from two ongoing Phase 1b studies of ONT-380 in combination showed promising systemic activity, a favorable safety profile and encouraging activity against brain metastases. Cascadian Therapeutics is also conducting a randomized, double-blind, placebo-controlled Phase 2 study called HER2CLIMB. The study is evaluating ONT-380 versus placebo in combination with capecitabine and trastuzumab in late stage HER2+ breast cancer patients, with and without brain metastases, who have previously been treated with a taxane, trastuzumab, pertuzumab and T-DM1.  This study is expected to enroll 180 patients with and without brain metastases across approximately 100 clinical sites in the U.S., Canada, and Western Europe. The Company is also developing a cell cycle inhibitor, Chk1, and plans to move the program forward through IND-enabling studies in 2017. For more information, visit www.cascadianrx.com.

Forward-Looking Statements
In order to provide Cascadian Therapeutics' investors with an understanding of its current results and future prospects, this release contains statements that are forward-looking. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will," "intends," "potential," "possible" and similar expressions are intended to identify forward-looking statements. These forward-looking statements include Cascadian Therapeutics' expectations regarding clinical development activities, timing of additional data, potential benefits of its product candidates, and its use and adequacy of cash reserves and future financial results.

Forward-looking statements involve risks and uncertainties related to Cascadian Therapeutics' business and the general economic environment, many of which are beyond its control. These risks, uncertainties and other factors could cause Cascadian Therapeutics' actual results to differ materially from those projected in forward-looking statements, including the risks associated with the costs and expenses of developing its product candidates, the adequacy of financing and cash, cash equivalents and investments, changes in general accounting policies, general economic factors, achievement of the results it anticipates from its preclinical development and clinical trials of its product candidates and its ability to adequately obtain and protect its intellectual property rights. Although Cascadian Therapeutics believes that the forward-looking statements contained herein are reasonable, it can give no assurance that its expectations are correct. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For a detailed description of Cascadian Therapeutics' risks and uncertainties, you are encouraged to review the documents filed with the securities regulators in the United States on EDGAR and in Canada on SEDAR. Except as required by law, Cascadian Therapeutics does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.

Additional Information
Additional information relating to Cascadian Therapeutics can be found on EDGAR at www.sec.gov and on SEDAR at www.sedar.com.

 
CASCADIAN THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(In thousands except share and per share amounts)
(Unaudited)
 
 Three months ended
June 30,

  Six months ended
June 30,

 
 2016
 2015  2016 2015 
              
Operating Expenses             
Research and development$    6,380  $5,701  $   12,717 $11,459 
General and administrative   4,365  2,636     10,998  4,957 
Intangible asset impairment    19,738       19,738   
Total operating expenses    30,483   8,337     43,453  16,416 
Loss from operations   (30,483) (8,337)    (43,453) (16,416)
Other income (expense)             
Investment and other income (expense), net   42  19     125  35 
Change in fair value of warrant liability   (2,578)    (2,450)
Total other income (expense), net   42  (2,559)    125  (2,415)
Net loss before income taxes$   (30,441)$(10,896) $   (43,328)$(18,831)
Income tax (benefit) provision   (6,908)       (6,908)  
Net loss   (23,533) (10,896)     (36,420) (18,831)
Deemed dividend related to beneficial conversion feature on Series D convertible preferred stock   (1,599)      (1,599)  
Net loss attributable to common stockholders   (25,132) (10,896)    (38,019) (18,831)
Net loss per share — basic and diluted$   (0.26)$(0.11) $   (0.40  )$(0.19)
Shares used to compute basic and diluted net loss per share 96,310,963  98,364,146   95,636,411  98,337,816 


     
 CASCADIAN THERAPEUTICS, INC. 
 Consolidated Balance Sheet Data 
 (In thousands except share amounts) 
 (Unaudited) 
     
  As of
    June 30, 2016 December 31, 2015
Cash, cash equivalents and investments $80,879   $56,360  
Total assets $100,828   $96,574  
Long term liabilities $262   $8,044  
Stockholders' equity $94,306   $83,735  
Common shares outstanding  135,310,441   94,961,859 
         

Source: Cascadian Therapeutics

Investor Contact:
Julie Rathbun
Rathbun Communications
206-769-9219
ir@cascadianrx.com

Tricia Truehart
The Trout Group
646-378-2953
ttruehart@troutgroup.com

Media Contact:
Amy Bonanno
BMC Communications
646-513-3117
abonanno@bmccommunications.com