Tokai Pharmaceuticals Inc (NASDAQ:TKAI), a biopharmaceutical company focused on developing and commercializing proprietary therapies for prostate cancer and other hormonally driven diseases, today reported results for the quarter ended June 30, 2015.

Tokai’s business highlights for the quarter include the initiation of ARMOR3-SV, Tokai’s pivotal Phase 3 clinical trial of galeterone in men with metastatic castration-resistant prostate cancer (mCRPC) whose tumor cells express the AR-V7 splice variant, which is a truncated form of the androgen receptor that has been associated with non-responsiveness to commonly-used oral therapies for mCRPC.

ARMOR3-SV is designed to evaluate whether administration of galeterone results in a statistically significant increase in radiographic progression free survival as compared to Xtandi® (enzalutamide) in 148 treatment-naïve mCRPC patients whose prostate tumor cells express the AR-V7 splice variant. This trial represents the first pivotal trial in prostate cancer that employs a precision medicine approach for patient selection. The design and clinical rationale for ARMOR3-SV was presented last quarter at the 2015 Annual Meeting of the American Society for Clinical Oncology. Topline data from ARMOR3-SV are anticipated by the end of 2016.

ARMOR3-SV has been initiated at 30 clinical centers in the United States, Canada and the United Kingdom, and regulatory approvals to begin the trial have been obtained in Belgium, France and Spain. A clinical trial assay that reliably detects the presence of AR-V7 in circulating tumor cells obtained from prostate cancer patients has been successfully developed by the Company’s collaborator, QIAGEN(NASDAQ: QGEN; Frankfurt Prime Standard: QIA). Implementation of the assay and training at the global central laboratories remain ongoing, and the Company continues to expect screening of eligible patients to begin this quarter.

“We believe that AR-V7 positive metastatic CRPC represents a significant unmet market opportunity, and that ARMOR3-SV has the potential to change the treatment landscape for metastatic CRPC patients by enabling treating physicians to make more informed treatment decisions,” said Jodie Morrison, President and Chief Executive Officer of Tokai. “We are pleased with our progress in initiating ARMOR3-SV globally, and with screening of patients beginning this quarter, we expect topline data from the study by the end of next year. With worldwide rights to galeterone and a pipeline of candidates from our ARDA discovery platform, a strong financial position and pivotal data expected next year, we are well positioned to create value from Tokai’s pipeline and achieve our mission of developing and delivering innovative therapies that provide hope and healing for patients living with cancer.”

Financial Results

  • Cash and investments at June 30, 2015 were $83.2 million, compared to $105.3 million at December 31, 2014.
  • Research and development expense was $5.9 million for the second quarter of 2015, as compared to $4.4 million for the same period of 2014. The increase in research and development expense was primarily attributable to start-up costs for the ARMOR3-SV clinical trial and the development of the AR-V7 clinical trial assay, and costs associated with other clinical trials to support the submission of a new drug application for galeterone.
  • General and administrative expense was $3.1 million for the second quarter of 2015, as compared to $1.5 million for the same period of 2014. The increase in general and administrative expense was primarily attributable to increased headcount and other expenses necessary to operate as a public company as well as increased patent costs.
  • Net loss was $9.0 million for the second quarter of 2015, compared to $5.9 million for the second quarter of 2014. (Original Source)

Shares of Tokai Pharmaceuticals closed today at $11.83, up $0.3 or 2.6%. TKAI has a 1-year high of $30 and a 1-year low of $9.67. The stock’s 50-day moving average is $13.28 and its 200-day moving average is $12.76.

On the ratings front, Tokai has been the subject of a number of recent research reports. In a report issued on May 14, BMO analyst Jim Birchenough maintained a Buy rating on TKAI, with a price target of $28, which implies an upside of 141.4% from current levels. Separately, on May 12, Oppenheimer’s Ling Wang initiated coverage with a Buy rating on the stock and has a price target of $38.

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jim Birchenough and Ling Wang have a total average return of 37.5% and -5.8% respectively. Birchenough has a success rate of 60.3% and is ranked #14 out of 3731 analysts, while Wang has a success rate of 35.7% and is ranked #3396.

Tokai Pharmaceuticals Inc is a clinical-stage biopharmaceutical company focused on developing novel proprietary therapies for the treatment of prostate cancer and other hormonally-driven diseases.