Tokai Pharmaceuticals Inc (NASDAQ:TKAI), a biopharmaceutical company focused on developing and commercializing innovative therapies for prostate cancer and other hormonally driven diseases, today reported company highlights and financial results for the year ended December 31, 2015.

“We have made substantial progress in the last several months, executing on our Phase 3 ARMOR3-SV trial globally and expanding our galeterone development program to include additional underserved patient populations with prostate cancer,” said Jodie Morrison, President and Chief Executive Officer of Tokai. “In ARMOR3-SV, we are gaining momentum in patient screening and enrollment throughout the world. In addition, the data unlocking galeterone’s distinct androgen receptor degradation mechanism presented at the ASCO Genitourinary Cancers Symposium provide further support for the differentiated profile of galeterone. We look forward to a number of important milestones throughout 2016 and into 2017 that we expect to elucidate the broad potential of galeterone in prostate cancer.”

Recent business highlights include:

  • Progress in ARMOR3-SV, a Phase 3 registration clinical trial of galeterone in AR-V7+ mCRPC. Over 100 clinical sites in the United States, Canada, Australia and Western Europe are open and actively screening patients in ARMOR3-SV, Tokai’s pivotal Phase 3 clinical trial evaluating whether administration of galeterone results in a statistically significant increase in radiographic progression free survival as compared to Xtandi®(enzalutamide) in treatment-naïve metastatic castration-resistant prostate cancer (mCRPC) patients whose prostate tumor cells express the AR-V7 splice variant. AR-V7 is a truncated form of the androgen receptor that has been associated with poor responsiveness to commonly used oral therapies for mCRPC. Screening experience in ARMOR3-SV to date indicates that the prevalence of AR-V7 continues to be in line with the company’s expectations and consistent with the published literature. Enrollment in ARMOR3-SV is expected to be completed during the second half of 2016, and top-line results from the trial are anticipated by mid-2017.
  • Expansion of galeterone clinical development into additional mCRPC populations.Tokai is expanding galeterone clinical development into additional mCRPC populations through the planned initiation of two additional studies in the first half of 2016 in patients who have shown resistance following treatment with either abiraterone or enzalutamide, including:
    • An open-label Phase 2 clinical trial that will evaluate galeterone in men whose mCRPC rapidly progressed following treatment with either abiraterone or enzalutamide.
    • An expansion of the ongoing Phase 2 clinical trial of galeterone (ARMOR2) in mCRPC patients who have developed acquired resistance to enzalutamide. This expansion follows results observed in a patient who, following an initial response to enzalutamide, experienced a PSA drop of over 90 percent when treated with galeterone. This patient’s PSA response has remained at less than 0.1µg/L for over a year.
  • Presentation of galeterone’s novel mechanism of action. At the ASCO Genitourinary Cancers Symposium held in January 2016, Tokai presented new data describing the novel mechanism by which galeterone degrades the androgen receptor (AR). These data demonstrate that galeterone selectively inhibits two deubiquitinating enzymes (DUBs) that are not inhibited by either Xtandi or Zytiga® (abiraterone acetate), resulting in degradation of the AR via the proteasome, regardless of the presence or absence of a ligand binding domain.

Financial Results

  • Cash and investments at December 31, 2015 were $64.0 million, as compared to $105.3 million at December 31, 2014.
  • Research and development expense for the year ended December 31, 2015 was $32.6 million as compared to $14.6 million for the year ended December 31, 2014. The increase in research and development expense was primarily attributable to the initiation of the ARMOR3-SV clinical trial and the development of the AR-V7 clinical trial assay during 2015, and costs associated with other clinical trials to support the submission of a new drug application for galeterone.
  • General and administrative expense for the year ended December 31, 2015 was $12.6 million, as compared to $8.9 million for the year ended December 31, 2014. The increase in general and administrative expense was primarily attributable to increased headcount, other expenses necessary to operate as a public company, increased patent costs and costs associated with pre-commercialization activities.
  • Net loss was $45.1 million for the year ended December 31, 2015, or $2.01 per share, as compared to $23.3 million for the year ended December 31, 2014, or $3.60 per share. (Original Source)

Shares of Tokai Pharmaceuticals closed yesterday at $6.24, down $-0.30 or -4.59%. TKAI has a 1-year high of $14.73 and a 1-year low of $4.93. The stock’s 50-day moving average is $6.22 and its 200-day moving average is $9.53.

On the ratings front, Oppenheimer analyst Ling Wang assigned a Buy rating on TKAI, in a report issued on February 11. According to TipRanks.com, Wang has a total average return of -26.5%, a 11.0% success rate, and is ranked #3687 out of 3694 analysts.

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.