Cascadian Therapeutics, Inc. (NASDAQ: CASC) is a clinical-stage biopharmaceutical company dedicated to developing innovative product candidates for the treatment of cancer. Its lead product candidate, tucatinib, is an investigational oral, selective small molecule HER2 inhibitor.
On November 8th, the company announced results for the quarter ended September 30, 2017, and provided an update on tucatinib, an investigational oral, small molecule kinase inhibitor that is highly selective for HER2 and the Company’s lead product in development for the treatment of HER2 overexpressing cancers.
Overall, CASC had a productive third quarter. Tucatinib was granted orphan drug designation for a second indication, HER2+ colorectal cancer and enrolment began for an investigator-sponsored study of tucatinib in combination with trastuzumab in HER2 amplified metastatic colorectal cancer.
Results from a pooled analysis of tucatinib combination studies were presented at ESMO that provide further support for the development of tucatinib in HER2+ metastatic breast cancer with brain metastases.
Near-term catalyst includes Regulatory feedback from the EMA, enrolment updates, reports from ongoing early-stage studies and initial data in other solid tumor settings. Also, the company is expected to share new follow up data from its tucatinib Phase 1b studies at the San Antonio Breast Cancer Symposium in early December. All these catalysts are expected to drive upside in the near to medium term.
Driven by the abovementioned factors, which are expected to translate into better prospects for the drug in the coming months, Traders and investors seem to be pricing CASC positively. The consensus expectation on the stock is buy with an average price target of $4.50. Considering present valuation, CASC is at a favorable risk-reward position.
About the company: Cascadian Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative product candidates for the treatment of cancer.
About Tucatinib: Tucatinib, is an investigational 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, each in combination with capecitabine and trastuzumab, in patients with locally advanced or metastatic HER2+ breast cancer with and without brain metastases, who have previously been treated with trastuzumab, pertuzumab, and T-DM1.
Third Quarter and Recent Highlights
- Tucatinib was granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of HER2+ colorectal cancer. This is the second orphan designation for tucatinib, which also has an orphan designation in breast cancer with brain metastases.
- Began enrollment in an investigator-initiated Phase 2 study of tucatinib in combination with trastuzumab for patients with HER2 amplified metastatic colorectal cancer. The study, known as MOUNTAINEER.
- Presented at the European Society for Medical Oncology 2017 Congress in September results from a pooled analysis of Phase 1b combination studies supporting the potential utility of tucatinib for patients with HER2+ metastatic breast cancer with brain metastases, including untreated or progressive brain metastases after radiation therapy.
- Additional analyses of long-term patients in tucatinib studies will be presented at the 40th San Antonio Breast Cancer Symposium 2017 in early December. In addition, results of non-clinical studies were presented that support the MOUNTAINEER study, demonstrating tucatinib is active as a single agent in models of HER2+ colorectal cancer, as well as in other gastrointestinal cancers.
- Continued enrollment of HER2CLIMB pivotal trial, which is on track and enrolling in North America, Western Europe and Australia.
- Received positive regulatory feedback from the European Medicines Agency’s (EMA) Scientific Advice Working Group and Health Canada, validating the potential for the ongoing HER2CLIMB pivotal clinical trial and nonclinical programs to be sufficient for tucatinib registration, if data are supportive.
- Management is pursuing partnering opportunities for CASC-578, a Chk1 kinase inhibitor, and CASC-674, a TIGIT antibody program, and is closing internal laboratory operations to focus resources on tucatinib registration-enabling critical path activities.
Third Quarter Financial Results
- Cash, cash equivalents, and investments totaled $113.0 million as of September 30, 2017, compared to $62.8 million at December 31, 2016. The increase was primarily due to net proceeds of $88.0 million from the Company’s January 2017 financing, less cash used in operations of $37.2 million.
- Net loss attributable to common stockholders for the three months ended September 30, 2017, was $14.1 million, or $0.28 per share, compared with a net loss attributable to common stockholders of $11.8 million, or $0.52 per share, for the comparable period in 2016.
2017 Financial Outlook
- Cascadian Therapeutics expects operating expenses in 2017 to be slightly higher than in 2016, primarily due to an increase in activities related to the ongoing worldwide HER2CLIMB pivotal trial. Cash used in operations for 2017 is expected to be approximately $50.0 million to $54.0 million.
- Cascadian Therapeutics believes the above financial guidance to be correct as of the date hereof and is providing the guidance as a convenience to investors and assumes no obligation to update it.
Key risk factors and potential stock drivers:
The favorable outcome of the upcoming catalysts (as mentioned above) is expected to provide a boost to the stock to retain its momentum. Any adversities related with the same could upset the stock performance significantly.
CASC presently has net level losses. Therefore, any crunch in its liquidity and financial flexibility will further impact its business & financial profile.
The company’s near-term stock movement is also dependent on its upcoming quarterly result, any major adversities/lower than expected guidance could adversely affect the investor sentiments.
Biotech space in itself is a high-risk sector due to uncertainties associated with the novel drug development. Therefore, favorable outcome of the upcoming catalyst is necessary for the stock to retain its momentum. Any adversities related to the same could impinge the stock performance significantly.
- On Monday, November 27th, 2017, CASC was at $4.25 (up by 3.41%) on volume of 391K shares exchanging hands. Market capitalization is $207.80 million. The current RSI is 56.02
- In the past 52 weeks, shares of CASC have traded as low as $3.18 and as high as $6.72
- At $4.25, shares of CASC are trading above its 50-day moving average (MA) at $4.18 and above its 200-day moving average (MA) at $4.00.
- The present support and resistance levels for the stock are at $4.05 & $4.24 respectively.
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