SEATTLE, Nov. 07, 2016 (GLOBE NEWSWIRE) -- Cascadian Therapeutics (NASDAQ:CASC), a clinical-stage biopharmaceutical company, today provided third quarter highlights and reported financial results for the quarter ended September 30, 2016.
"We continue to make strides on the clinical development front as we advance tucatinib in combination for patients with metastatic HER2+ breast cancer, including those with and without brain metastases," said Scott Myers, CEO of Cascadian Therapeutics. "There is significant need for improved therapies in this disease, and we continue to be impressed by the favorable safety profile observed in the tucatinib combination studies to date when compared with other HER2 therapies, as well as its potential to treat systemic disease and positively impact brain metastases."
Mr. Myers added, "We are looking forward to the presentation of updated clinical data from our ongoing Phase 1b ‘Triplet' study of tucatinib plus capecitabine and trastuzumab at the San Antonio Breast Cancer Symposium in December, as well as updating everyone on our clinical and regulatory plans later this quarter."
THIRD QUARTER AND RECENT HIGHLIGHTS
THIRD QUARTER 2016 FINANCIAL HIGHLIGHTS
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 $71.6 million as of September 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, tucatinib, 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 tucatinib 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 tucatinib 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.
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.
|CASCADIAN THERAPEUTICS, INC.|
|Condensed Consolidated Statements of Operations|
|(In thousands except share and per share amounts)|
|Three months ended||Nine months ended|
|September 30,||September 30,|
|Research and development||$||7,281||$||5,122||$||19,998||$||16,581|
|General and administrative||3,511||2,100||14,509||7,057|
|Intangible asset impairment||—||—||19,738||—|
|Total operating expenses||10,792||7,222||54,245||23,638|
|Loss from operations||(10,792||)||(7,222||)||(54,245||)||(23,638||)|
|Other income (expense)|
|Investment and other income (expense), net||19||25||144||60|
|Change in fair value of warrant liability||—||2,578||—||128|
|Total other income (expense), net||19||2,603||144||188|
|Net loss before income taxes||$||(10,773||)||$||(4,619||)||$||(54,101||)||$||(23,450||)|
|Income tax (benefit) provision||—||—||(6,908||)||—|
|Deemed dividend related to beneficial conversion feature on Series D convertible preferred stock||(989||)||—||(2,588||)||—|
|Net loss attributable to common stockholders||(11,762||)||(4,619||)||(49,781||)||(23,450||)|
|Net loss per share — basic and diluted||$||(0.09||)||$||(0.05||)||$||(0.46||)||$||(0.24||)|
|Shares used to compute basic and diluted net loss per share||135,310,441||94,914,536||108,957,618||97,184,183|
|CASCADIAN THERAPEUTICS, INC.|
|Consolidated Balance Sheet Data|
|(In thousands except share amounts)|
|September 30, 2016||December 31, 2015|
|Cash, cash equivalents and investments||$||71,638||$||56,360|
|Long term liabilities||$||165||$||8,044|
|Common shares outstanding||135,310,441||94,961,859|
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