On May 10, 2016 Tokai Pharmaceuticals, Inc. (NASDAQ: TKAI), a biopharmaceutical company focused on developing and commercializing innovative therapies for prostate cancer and other hormonally driven diseases, reported company highlights and financial results for the quarter ended March 31, 2016 (Press release, Tokai Pharmaceuticals, MAY 10, 2016, View Source;p=RssLanding&cat=news&id=2166824 [SID:1234512193]).
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"Over the past quarter we have made significant progress in our clinical development program for galeterone, as we continued to accelerate screening and enrollment in our ARMOR3-SV trial and expanded our Phase 2 trial to include additional mCRPC patients who have acquired resistance to enzalutamide," said Jodie Morrison, President and Chief Executive Officer of Tokai. "We have also strengthened our development team to sharpen focus on execution of our clinical trials, and we look forward to continued progress in the months ahead as we work with great urgency to meet the needs of patients who currently have limited therapeutic options."
Recent business highlights include:
Progress in ARMOR3-SV, a Phase 3 registration trial of galeterone in AR-V7+ mCRPC. Patient enrollment is ongoing in ARMOR3-SV, Tokai’s pivotal Phase 3 clinical trial evaluating whether administration of galeterone results in a statistically significant and clinically meaningful improvement 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 response to commonly-used oral therapies for mCRPC. Over 100 clinical sites in eight countries are actively screening patients for potential eligibility to participate in ARMOR3-SV. Enrollment in ARMOR3-SV is expected to be completed by the end of 2016, and top-line data from the trial are anticipated by mid-2017.
Expansion of galeterone clinical development program. In March, patient dosing began in 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.
Strengthening of development team. Tokai enhanced its development capabilities with the addition of Kelly A. Lindert, M.D., as Executive Vice President and Head of Development responsible for the company’s clinical development, medical affairs, pharmacovigilance, regulatory affairs and quality assurance activities.
Financial Results
Cash and investments at March 31, 2016 were $54.3 million, as compared to $64.0 million at December 31, 2015.
Research and development expense for the quarter ended March 31, 2016 was $7.9 million, as compared to $10.6 million for the quarter ended March 31, 2015. Research and development expense in the first quarter of 2015 included a one-time fee paid to Qiagen Manchester Limited to access rights to its proprietary circulating tumor cell technology for use in the AR-V7 clinical trial assay. The decrease in research and development expense was also attributable to decreased manufacturing costs during the first quarter of 2016, partially offset by an increase in clinical trial costs associated with ARMOR3-SV.
General and administrative expense for the quarter ended March 31, 2016 was $3.5 million, as compared to $2.7 million for the quarter ended March 31, 2015. The increase in general and administrative expense was primarily attributable to increased headcount associated with operating as a public company, including related stock-based compensation expense.
Net loss was $11.4 million for the quarter ended March 31, 2016, or $0.51 per share, as compared to $13.3 million for the quarter ended March 31, 2015, or $0.59 per share.