Restructuring, Workforce

Cash-strapped Regulus braces for drastic downsizing while hitting the brakes on lead programs

Still suffering from financial woes triggered by a streak of setbacks over the past two years, Regulus Therapeutics is now putting its two clinical programs on hold — and axing 60% of its remaining staff.

The news landed quietly just after the July 4th holiday, which didn’t prevent Regulus’ already battered stock price $RGLS from taking a steep dive of 52% to date. Altogether, the changes are expected to translate into $20 million in annualized savings, fueling the company through mid-2019 when added to the $45.1 million the company already has in the bank as of March 31.

Jay Hagan

A joint venture created by Alnylam and Ionis in 2007 to develop microRNA therapies, Regulus’ clinical programs barely took off before it got slammed with a full clinical hold from the FDA in 2016, after two patients taking RG-101, its RNAi treatment for hepatitis C, began developing jaundice. Having booted its CEO and slashed 30% of its staff last May, the La Jolla, CA-based biotech put the program to bed a month later as it chopped another program and saw AstraZeneca walk away from a partnership on NASH.

RG-012, a Sanofi-partnered program vaulted to the lead position after the saga, was supposed to be Regulus’ saving grace. But now, recruitment activities for the PhII trial are coming to a halt “while discussions with Sanofi to potentially restructure the partnership are ongoing.”

“I am very disappointed that we need to take these drastic steps to preserve our capital, especially given the significant contributions by our dedicated employees to the progress made toward unlocking the potential of targeting microRNAs,” said president and CEO Jay Hagan, who got promoted to the job in the last restructuring, in a statement.

Right now, Hagan added, Regulus will focus on resolving some surprise toxicity issues identified in a mouse study of RGLS4326, a drug intended to treat autosomal dominant polycystic kidney disease. While they conduct a second 27-week mouse chronic toxicity study featuring changes that they hope will address the concerns, the Phase I trial will be on pause.

Regulus emphasized that they are also working on a preclinical program in HBV, which they are branding as “the most attractive opportunity in its pipeline for investment.” The plan is to file an IND in the second of 2019 — if they haven’t run out of money by then.

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