Regado Biosciences will idle 60% of its workforce—20 employees—in a cost-cutting move one month after terminating the development program for its lead product Revolixys, an anticoagulant linked to severe allergic reactions among patients in a Phase III trial.
The company said it will focus going forward on completing final closure of the REGULATE-PCI trial, and analysis of its unblinded database – something expected in the fourth quarter—as well as “thoroughly” exploring potential business alternatives and carrying out its compliance duties as a public company.
“The termination of REGULATE-PCI led us to important business decisions,” Regado CEO David J. Mazzo, Ph.D., said yesterday in a statement. “The workforce reduction was a necessary action to conserve working capital and provide maximum flexibility in determining the future direction of Regado.”
Mazzo said the company has begun to evaluate “a broad range of strategic alternatives that could maximize returns for Regado shareholders in the near future.” Regado said it retained MTS Health Partners, and Cowen and Company to serve as strategic advisors.
The layoffs will occur “across all operational sites,” Regado added, and will result in the company taking a $2 million fourth-quarter charge in connection with one-time termination costs and facility shutdown expenses.
Regado projected it will finish the third quarter with a cash balance of about $61 million, with final trial closing costs and ongoing operational costs expected to lower the projected cash balance for the end of 2014. The company said it will provide further when it reports third-quarter results.
Revolixys is a combination of the Factor IXa inhibitor anticoagulant pegnivacogin and its complementary oligonucleotide active control agent, anivamersen. The treatment was designed for patients suffering from acute coronary syndrome (ACS), including those who undergo coronary revascularization procedures, which include percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG).
Regardo halted REGULATE-PCI trial in August after its Data and Safety Monitoring Board indicated that the level of serious allergic adverse events associated with Revolixys “was of a frequency and severity such that they recommended that we do not enroll any further patients,” according to a company statement issued at the time that did not offer details.
The trial was funded using $51 million in Series E financing that Regado secured in December 2012. The round was led by new investor RusnanoMedInvest, a subsidiary of the state-run Russian investment firm RUSNANO, and included participation from another new investor, Baxter Healthcare’s venture initiative, Baxter Ventures. Existing investors Edmond de Rothschild Investment Partners, Domain Associates, Quaker Partners, Aurora Funds and Caxton Advantage Life Sciences Fund also participated in the round.