Exhibit 99.1

 

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Regulus Reports Fourth Quarter and Year-End 2014 Financial Results and Recent Highlights

- Achieved Key 2014 ‘Clinical Map Initiative’ Goals to Advance microRNA Therapeutics Pipeline -

- Exceeded Guidance Ending 2014 with $159.7 Million in Cash -

LA JOLLA, Calif., February 18, 2015

Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today reported financial results for the fourth quarter and year ended December 31, 2014, including a summary of recent corporate highlights.

“In 2014 and the start of 2015, Regulus has demonstrated significant progress toward our goal of building a leading biopharmaceutical company dedicated to discovering and developing a new and major class of medicines targeting microRNAs,” said Kleanthis G. Xanthopoulos, Ph.D., President and CEO of Regulus. “In 2014, we achieved key goals under our ‘Clinical Map Initiative’ to advance our microRNA therapeutics pipeline, with the most significant being the human proof-of-concept results demonstrated with RG-101, our wholly-owned GalNAc-conjugated anti-miR-122 for the treatment of HCV. We are pleased with our continued execution and our ‘Clinical Map Initiative’ goals for 2015 remain on track.”

Paul Grint, M.D., Chief Medical Officer of Regulus, added, “Our scientific accomplishments in 2014 positioned Regulus for an exciting year focused on the growth of our clinical portfolio. Currently, we are preparing to initiate Phase II studies for RG-101 in multiple countries and our first clinical studies for RG-012, an anti-miR targeting microRNA-21, to treat a devastating orphan disease with no approved therapy called Alport syndrome. Throughout the year, we look forward to reporting progress on these goals and on the overall advancement of our portfolio.”

Fourth Quarter 2014 and Recent Highlights

 

   

Achieved Human Proof-of-Concept with RG-101 in HCV. Treatment with a single subcutaneous dose of either 2 mg/kg or 4 mg/kg of RG-101, a GalNAc-conjugated anti-miR targeting microRNA-122 (“miR-122”), as monotherapy resulted in significant and sustained viral load reductions in all treated HCV patients, including patients with difficult to treat genotypes, various liver fibrosis status and those who have experienced viral relapse after a prior IFN-containing regimen. At day 29, mean viral load reductions of 4.8 log10 and 4.1 log10 were demonstrated in the 4 mg/kg and 2 mg/kg single dose cohorts, respectively. At day 57, 15 out of 28 patients treated with one single administration of either 2 mg/kg or 4 mg/kg of RG-101 had HCV RNA levels below the

 

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The following information was filed by Regulus Therapeutics Inc. (RGLS) on Wednesday, February 18, 2015 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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