Regulus Therapeutics said it is eliminating 30% of its workforce—approximately 30 jobs—in a restructuring that includes a change at the helm, with president and CEO Paul Grint, M.D., resigning effective immediately.
The company had 97 employees as of December 31, 2016, according to its Form 10-K annual report for 2016, filed March 3: “Of these employees, 77 employees are engaged in R&D activities and 20 employees are engaged in finance, legal, human resources, facilities, and general management.”
Dr. Grint will be succeeded by COO Joseph P. “Jay” Hagan, while the company’s vp of finance and accounting, Daniel R. Chevallard, has been promoted to CFO.
The managerial changes are part of a restructuring disclosed by Regulus yesterday after the close of trading, with the goal of streamlining its operations and focusing on what it considers its most promising discovery and development programs.
In June 2016, the FDA placed a clinical hold on Regulus’ chronic hepatitis C virus (HCV) candidate RG-101. The hold followed the company’s disclosure that a second serious adverse event of jaundice serious adverse event (SAE) occurred in a HCV patient with end-stage renal disease on dialysis who was enrolled in its on-going Phase I U.S. study, 117 days after receiving a single dose of RG-101.
Regulus acknowledged in January that the clinical hold would remain in effect for most of this year, after the FDA requested final safety and efficacy data from on-going RG-101 clinical and preclinical studies before reconsidering whether to lift the hold. The company said that data will be available once current study protocols are complete through 48 weeks of follow-up, which is anticipated in Q4.
Yesterday, investors reacted to the restructuring announcement by sending share prices tumbling 18% from yesterday’s close of $1.70, to $1.39 as of 9:57 a.m.
“We continue to advance our clinical and preclinical pipeline, and, importantly, are on track to commence the Phase II HERA and renal biopsy studies for RG-012 as planned,” Hagan said in a statement.
RG-012 is a treatment candidate for Alport Syndrome that Regulus is developing with Genzyme, a Sanofi company. RG-012 is a single-stranded, chemically modified oligonucleotide that is designed to work by binding to and inhibiting the function of microRNA-21.
Regulus said it has completed dosing of RG-012 in its Phase I multiple ascending dose (MAD) study, and has selected the dose for the upcoming Phase II HERA and renal biopsy studies, which are expected to begin in mid 2017. Data from the renal biopsy study is anticipated by the end of this year, while interim data from the Phase II HERA study is anticipated in mid 2018, Regulus said.
RG-012 has received orphan drug status from the FDA and European Commission as a treatment for Alport syndrome.
Regulus disclosed the restructuring as it reported first-quarter results. The company finished Q1 with a net loss of $20 million, compared with a net loss of $21.2 million in the year-ago quarter. Q1 revenue was less than $0.1 million, down from $0.5 million during Q1 2016.
