Tokai Pharmaceuticals said today its board has launched a review of strategic alternatives “focused on maximizing stockholder value,” more than a month after the company began eliminating more than half its staff following the failure of its lead candidate in a Phase III trial.
“Potential strategic alternatives that may be explored or evaluated as part of this review include a sale of the company, a reverse merger, a business combination, or a sale, license, or other disposition of corporate assets of the company,” Tokai said in a statement.
The company has hired Wedbush PacGrow as its financial advisor in connection with its strategic review.
“There is no set timetable for this process,” Tokai added.
Tokai’s action comes nearly 6 weeks after the company disclosed plans to eliminate approximately 60% of its workforce—about 15 jobs—by the end of the third quarter, leaving the company with 10 full-time employees.
The job cuts were revealed July 29, 3 days after the company said it was ending the Phase III ARMOR3-SV trial comparing its lead candidate galeterone to Xtandi® (enzalutamide) in a form of metastatic castration-resistant prostate cancer (mCRPC).
The company cited the trial’s independent Data Monitoring Committee, which concluded that ARMOR3-SV was unlikely to meet its primary endpoint of demonstrating improved radiographic progression-free survival (rPFS) for galeterone versus enzalutamide in treatment-naïve mCRPC patients whose prostate tumors express androgen receptor splice variant-7 mRNA (AR-V7).
“The company is continuing to assess the best path forward for its galeterone clinical trial program,” Tokai stated today. “The company now anticipates all patients enrolled in the ARMOR3-SV clinical trial will discontinue treatment by the end of the year.”
Tokai last month quietly backed away from two other galeterone-related trials, stating in an August 22 regulatory filing that it opted to end enrollment in its ongoing ARMOR2 expansion clinical trial of galeterone in mCRPC patients with acquired resistance to Xtandi and was not proceeding with a planned study of galeterone in mCRPC patients who rapidly progress on either enzalutamide or Zytiga® (abiraterone acetate).