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7	7	Cascadian Therapeutics (CASC) is a clinical-stage biopharmaceutical company focused on the development of therapeutic products for the treatment of cancer. The company's goal is to develop and commercialize novel targeted compounds that have the potential to improve the lives and outcomes of cancer patients. The company's lead clinical-stage product candidate is tucatinib, an oral, HER2-selective small molecule tyrosine kinase inhibitor. The company's pipeline also includes two preclinical-stage product candidates: CASC-578, a Chk1 kinase inhibitor, and CASC-674, an antibody program against an immuno-oncology target known as TIGIT.
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9		-==== 2018 Merger Agreement ====
	9	+= 2018 Merger Agreement =
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11	11	On January 30, 2018, the company entered into an Agreement and Plan of Merger (the Merger Agreement) with Seattle Genetics, Inc., a Delaware corporation (Seattle Genetics), and Valley Acquisition Sub, Inc., a Delaware corporation and a wholly owned subsidiary of Seattle Genetics (Merger Sub). Pursuant to the Merger Agreement, and upon the terms and subject to the conditions thereof, on February 8, 2018, Merger Sub commenced a tender offer (the Offer) to acquire all of its issued and outstanding shares of common stock (the Shares) at a purchase price of $10 per Share (the Offer Price), net to the seller in cash, without interest and subject to any required withholding taxes.
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13	13	Following the consummation of the Offer and subject to the terms and conditions of the Merger Agreement, Merger Sub will merge with and into Cascadian Therapeutics, with Cascadian Therapeutics surviving as a subsidiary of Seattle Genetics (the Merger, and together with the Offer, the Transactions). The Merger will be effected pursuant to Section 251(h) of the General Corporation Law of the State of Delaware, without a vote of stockholders of Cascadian Therapeutics. At the effective time of the Merger, each Share (other than Shares owned by Seattle Genetics, Merger Sub, or any other direct or indirect wholly owned subsidiary of Seattle Genetics, and Shares owned by Cascadian Therapeutics, or any direct or indirect wholly owned subsidiary of the Company, or by stockholders who have validly exercised their appraisal rights under Delaware law) will be converted into the right to receive an amount in cash equal to the Offer Price, without interest and subject to any required withholding taxes.
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15		-==== Tucatinib ====
	15	+= Tucatinib =
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17	17	The company's lead development candidate, tucatinib, is an investigational orally bioavailable, potent tyrosine kinase inhibitor (TKI) that is highly selective for HER2, also known as ErbB2, a growth factor receptor that is over-expressed in approximately 20% of breast cancers. In addition to breast cancer, HER2 is over-expressed in other malignancies, including subsets of bladder, cervical, colorectal, esophageal, gastric, lung and ovarian cancers. Cascadian Therapeutics is currently developing tucatinib for the treatment of HER2-positive (HER2+) metastatic breast cancer. Over-expression of HER2 in breast cancer has been associated historically with increased mortality in early stage disease, decreased time to relapse and increased incidence of metastases. Similarly, the overexpression of HER2 is thought to play an important role in the development and progression of other cancers.
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41	41	Cascadian Therapeutics has an exclusive license agreement with Array BioPharma Inc. for the worldwide rights to develop, manufacture and commercialize tucatinib.
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43		-==== Other Pipeline Candidates ====
	43	+= Other Pipeline Candidates =
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45	45	Although its efforts are focused primarily on developing and commercializing tucatinib, Cascadian Therapeutics has two preclinical programs. The company's earlier stage product candidates are CASC-578, a Chk1 cell cycle inhibitor that is an orally available, small molecule kinase inhibitor, and CASC-674, an antibody against an immuno-oncology target known as TIGIT.
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66	66	|Chk1|Small Molecule|To be determined|Preclinical
67	67	|TIGIT|Antibody|To be determined|Preclinical
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69		-==== Oncology Market Overview and Opportunity ====
	69	+== Oncology Market Overview and Opportunity ==
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71	71	Breast cancer is the most common form of cancer in women worldwide, and the second leading cause of cancer-related death in women in North America. The American Cancer Society estimated that in 2017 more than 250,000 women in the U.S. would develop breast cancer and more than 40,000 would die from the disease. Approximately 15-20% of breast cancers overexpress HER2.
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75	75	The prevention and treatment of metastatic disease in the central nervous system (CNS), including brain metastases, remains a significant unmet medical need for patients with HER2+ breast cancer. The incidence of first relapse occurring in the brain is increasing in patients who have progressed following trastuzumab-containing adjuvant regimens, and approximately 30-50% of patients with HER2+ metastatic disease will develop brain metastases over the course of their disease.
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77		-==== Development Candidates ====
	77	+== Development Candidates ==
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79	79	**Tucatinib**
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105	105	In December 2016, the company reported that following a meeting with the FDA and discussions with its external Steering Committee, the company had amended the ongoing HER2CLIMB Phase 2 clinical trial of tucatinib by increasing the sample size so that, if successful, the trial could serve as a single pivotal study to support registration. HER2CLIMB is a randomized (2:1), double-blind, controlled pivotal clinical trial comparing tucatinib vs. placebo in combination with capecitabine and trastuzumab in patients with locally advanced or metastatic HER2-positive breast cancer who have had prior treatment with a taxane, trastuzumab, pertuzumab and T-DM1.The primary endpoint remains PFS based upon independent radiologic review, and the sample size has increased to approximately 480 patients, including patients already enrolled in the trial. Key objectives related to assessing activity in brain metastases include a key secondary endpoint of PFS in a subset of patients with brain metastases. All patients will be followed for overall survival.
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107		-==== Preclinical Programs ====
	107	+== Preclinical Programs ==
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109	109	**Checkpoint kinase 1 inhibitor**
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117	117	Cascadian Therapeutics has identified novel antibodies to TIGIT, an immune receptor that may block the induction of adaptive and innate immune response to cancers. The TIGIT antibody program is in preclinical development and is part of the collaborative effort with Adimab for the discovery of novel antibodies against immunotherapy targets. See Part I, Item 1, “Business—Collaborations” for additional information.
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119		-==== License and Collaboration Agreements ====
	119	+= License and Collaboration Agreements =
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121	121	Array BioPharma Inc. In December 2014, the company entered into a license agreement with Array. Pursuant to the license agreement, Array has granted it an exclusive license to develop, manufacture and commercialize tucatinib. The license agreement replaced a development and commercialization agreement under which the company and Array were previously jointly developing tucatinib. As part of the agreement, the company paid Array $20 million as an upfront fee. In addition, the company will pay Array a portion of any payments received from sublicensing tucatinib rights. Array is also entitled to receive up to a low double-digit royalty based on net sales of tucatinib by it and a single-digit royalty based on net sales of tucatinib by its sublicensees. The term of the license agreement expires on a country-by-country basis upon the later of the expiration of the last valid claim covering tucatinib within that country or 10 years after the first commercial sale of tucatinib within that country.
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141	141	Certain jurisdictions, including the U.S., Japan and Europe, provide mechanisms for restoring a period of patent term consumed by regulatory review. The company plan to take advantage of all opportunities to extend the patent term in each jurisdiction where Cascadian Therapeutics is able to do so.
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143		-==== Manufacturing ====
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145	145	The company use third party contractors to procure the necessary materials and manufacture, as applicable, starting materials, active pharmaceutical ingredients and finished drug product, as well as for labeling, packaging, storage and distribution of its compounds. This arrangement allows it to use contract manufacturers that have extensive Good Manufacturing Practices, or cGMP, manufacturing experience. Cascadian Therapeutics has a staff with experience in the management of contract manufacturing and in the development of efficient commercial manufacturing processes for its products candidates. The company currently intend to outsource the manufacture of all its commercial products.
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160	160	Tucatinib. Tucatinib is an inhibitor of the receptor tyrosine kinase HER2, also known as ErbB2. Multiple marketed products target HER2, including the antibodies trastuzumab (Herceptin®) and pertuzumab (Perjeta®) and the antibody toxin conjugate ado-trastuzumab emtansine (Kadcyla®), all from Roche/Genentech. In addition, GlaxoSmithKline markets the dual HER1/HER2 oral kinase inhibitor lapatinib (Tykerb®) for the treatment of metastatic breast cancer, Puma Biotechnology is developing the HER1/HER2/HER4 inhibitor neratinib in Phase 3 clinical trials.
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162		-==== Research and Development ====
	162	+= Research and Development =
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164	164	The company devote a substantial portion of its resources to developing new product candidates. During the years ended December 31, 2017, 2016 and 2015, the company expended approximately $44.0 million, $27.5 million and $23.5 million, respectively, on research and development activities. Higher research and development expenses during the year ended December 31, 2017 was primarily due to greater activity related to the development of its product candidates.
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166		-==== Employees ====
	166	+= Employees =
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168	168	As of December 31, 2017, the company had 71 employees. A number of its management and professional employees have had prior experience with other pharmaceutical or medical products companies.
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