SEATTLE, March 09, 2017 (GLOBE NEWSWIRE) -- Cascadian Therapeutics, Inc. (NASDAQ:CASC) today reported financial results for the fourth quarter and full year ended December 31, 2016.
"In 2016, we focused our efforts on the development of tucatinib for late-stage HER2-positive metastatic breast cancer for patients with and without brain metastases and amended our ongoing HER2CLIMB study by increasing the sample size so that, if successful, the trial could serve as a single pivotal trial to support registration," said Scott Myers, President and CEO of Cascadian Therapeutics. "For 2017, we have prioritized our resources on expanding HER2CLIMB globally and exploring the potential utility of tucatinib in additional HER2-positive expressing cancers. With a global development plan underway, clarity on a U.S. regulatory pathway and a solid financial position, we have set the foundation to execute our strategy."
Fourth Quarter and Recent Highlights
Tucatinib — targeted HER2 inhibitor
CASC-578 — a novel Chk1 cell cycle inhibitor
Fourth Quarter and Full Year 2016 Financial Results
2017 Financial Outlook
Cascadian Therapeutics believes the following financial guidance to be correct as of the date provided and is providing the guidance as a convenience to investors and assumes no obligation to update it.
Cascadian Therapeutics expects operating expenses in 2017 to be slightly higher than in 2016, which included a one-time expense associated with the intangible asset impairment. The 2017 increase is due to an increase in activities related to the ongoing HER2CLIMB pivotal trial. Cash used in operations is expected to be approximately $50.0 million to $54.0 million.
About Cascadian Therapeutics
Cascadian Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative product candidates for the treatment of cancer. The lead product candidate, tucatinib, is an oral, selective small molecule HER2 inhibitor. Cascadian Therapeutics is conducting a randomized, double-blind controlled pivotal clinical trial called HER2CLIMB, which is comparing tucatinib vs. placebo in combination with capecitabine and trastuzumab in patients with locally advanced or metastatic HER2-positive breast cancer with and without brain metastases, who have previously been treated with a taxane, trastuzumab, pertuzumab and T-DM1. Additional details on HER2CLIMB can be found at www.clinicaltrials.gov (Identifier: NCT02614794) or www.HER2CLIMB.com. For more information, please visit www.cascadianrx.com.
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, the receipt of regulatory approvals, 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.
|CASCADIAN THERAPEUTICS, INC.|
|Consolidated Statements of Operations|
|(In thousands except share and per share amounts)|
|Three months ended|
|Research and development||$||7,469||$||6,887||$||27,467||$||23,468|
|General and administrative||3,121||2,264||17,630||9,321|
|Intangible asset impairment||—||—||19,738||—|
|Total operating expenses||10,590||9,151||64,835||32,789|
|Loss from operations||(10,590||)||(9,151||)||(64,835||)||(32,789||)|
|Other income (expense)|
|Investment and other income (expense), net||78||20||222||80|
|Change in fair value of warrant liability||—||—||—||128|
|Total other income (expense), net||78||20||222||208|
|Net loss before income taxes||$||(10,512||)||$||(9,131||)||$||(64,613||)||$||(32,581||)|
|Income tax (benefit) provision||—||—||(6,908||)||—|
|Deemed dividend related to beneficial conversion feature on Series D convertible preferred stock||—||—||(2,588||)||—|
|Net loss attributable to common stockholders||(10,512||)||(9,131||)||(60,293||)||(32,581||)|
|Net loss per share — basic and diluted||$||(0.47||)||$||(0.58||)||$||(3.13||)||$||(2.02||)|
|Shares used to compute basic and diluted net loss per share||22,553,642||15,822,410||19,264,121||16,102,860|
|CASCADIAN THERAPEUTICS, INC.|
|Consolidated Balance Sheet Data|
|(In thousands except share amounts)|
|December 31, 2016||December 31, 2015|
|Cash, cash equivalents and investments||$||62,805||$||56,360|
|Long term liabilities||$||135||$||8,044|
|Common shares outstanding||22,562,640||15,826,985|
Investor and Media Contact: Monique Greer Cascadian Therapeutics 206-801-2107 email@example.com