May 5, 2017
By Alex Keown, BioSpace.com Breaking News Staff
LA JOLLA, Calif. – Shares of Regulus Therapeutics are down more than 31 percent in premarket trading as its chief executive officer resigns amid an ongoing clinical hold of its lead product and the company initiates a corporate restructuring plan that includes the termination of 30 percent of employees.
Paul Grint, president and CEO of Regulus, tendered his immediate resignation Thursday afternoon, which the board accepted, according to a company statement. Joseph P. “Jay” Hagan, chief operating officer of Regulus, has been tapped to replace Grint. Daniel Chevallard, Regulus’ vice president of finance and accounting has been moved to the position of CFO.
Not only did the CEO leave, but Regulus also handed out pink slips to 30 percent of its employees, a move the company said should save $6 million annually after one-time restructuring costs. The company reported 97 employees at the end of 2016, Endpoints noted this morning in its report.
With the shakeup, the company’s board of directors set out to reassure investors that the change in leadership will keep the company on the right track, particularly as it relates to RG-101, a GalNAc-conjugated anti-miR targeting microRNA-122 for the treatment of chronic hepatitis C virus infection. Targeting microRNAs with anti-miRs, chemically modified, single-stranded oligonucleotides, offers a unique approach to treating disease by modulating entire biological pathways and may become a new and major class of drugs with broad therapeutic application, Regulus said.
But, RG-101 ran into some problems and was placed on clinical hold by the U.S. Food and Drug Administration last year and currently remains there. RG-101 was placed on hold in June 2016 after Regulus reported a second serious adverse event of jaundice. In July 2016, the company said it anticipated providing all of the necessary data to the FDA to answer questions, but in January of this year the regulatory agency requested additional expert review of liver safety data. That data though will not be had until the end of 2017, which leaves that therapy hanging in the wind and losing ground to other HCV treatments, such as Gilead’s Harvoni and Sovaldi.
New CEO Hagan attempted to put a positive spin on things. In a statement, he said the company’s priorities remain on its most promising programs and touted another microRNA candidate, RG-012 for the treatment of Alport Syndrome. Alport Syndrome is a genetic disease that leads to the loss of kidney function. The company expects to begin Phase II trials and a renal biopsy study for that therapy by the middle of 2017. Preliminary data from the Phase I study indicated that RG-012 was well tolerated with no serious adverse events reported in any subjects, the company said. Data from the renal biopsy study is anticipated by year-end 2017 and interim data from the Phase II study is anticipated in mid-2018.
Regulus closed out the first quarter with cash and cash-equivalents of $57.5 million, as of March 31. That was down from the $76.1 million the company reported as of Dec. 31, 2016.
