Regulus nabs $30M in debt to keep plugging at microRNA-targeting hep C candidate

MicroRNA

Small cap Regulus Therapeutics ($RGLS) has nabbed a $30 million credit facility from Oxford Finance that it said is sufficient to get it into 2018. Most of the money is already earmarked to back its Phase II clinical program for lead candidate RG-101.

The company hopes that its RG-101 can eradicate HCV in four weeks or less--which would be much faster than existing treatments that require about 8 to 12 weeks of therapy. Earlier this month, Regulus expanded its clinical trial deal with GlaxoSmithKline ($GSK) to develop RG-101 with a trial that aims to enable a cure in just one visit. The candidate targets microRNA-122, which the virus uses to replicate.

The partners added a study slated to start in the fourth quarter--a multi-centered, randomized, dose-ranging Phase II study evaluating the combination of RG-101 and GSK's long-acting parenteral formulation of GSK2878175 as a potential single-visit cure in patients chronically infected with HCV. Interim data from the trial is expected in the second half of 2017, with a pivotal study to start potentially in late 2017.

Of the $30 million loan, $20 million is available upfront to support of Phase II development of RG-101 with the remaining $10 million contingent on undisclosed milestones. The facility matures on June 1, 2020. It is interest-only for the first 24 months and has an interest rate equal to the sum of 8.51% plus the greater of 0.44% or the three-month LIBOR rate.

"Access to this non-dilutive capital provides us with significant additional financial resources to advance our clinical development programs, and importantly, extends our cash runway into 2018," said Regulus CEO Dr. Paul Grint in a statement. "We are pleased with the terms of the loan and the flexibility it offers us as we look to generate important new clinical data from our pipeline."

The latest RG-101 data came earlier this month with top-line data from an ongoing Phase II. It showed that a four-week regimen in 79 treatment naïve genotype 1 and 4 HCV patients of RG-101 subcutaneously with once-daily approved anti-viral agents Harvoni, Olysio or Daklinza. It resulted in a 100% response rate at 24 weeks for Harvoni--with 80% for Olysio and almost 90% for Daklinza.

“RG-101 stands alone as the only agents to date to demonstrate significant viral load reductions in the majority of patients treated with just a four week treatment course in combination with available DAAs,” summed up Regulus CEO Paul Grint on a May conference call. “Based on the results we’ve seen thus far, we believe that RG-101 is uniquely positioned to help address this global healthcare problem.”

- here is the release

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